Macular Degeneration News Archive
(2006 and Before)

...continued from Current Macular Degeneration News

Study Will Examine Effectiveness of
Combined Therapies for AMD

EAST HANOVER, N.J., November 2006 — A study that combines two U.S. Food and Drug Administration-approved drugs for advanced macular degeneration will examine whether outcomes can be improved and the frequency of treatments reduced, Novartis Pharmaceuticals Corp. officials announced in November 2006.

The study in the United States and Canada soon will enroll about 300 individuals with advanced macular degeneration, a form that involves abnormal blood vessel growth in the inner back of the eye (retina) known as choroidal neovascularization or CNV.

Combined treatments will include regular use of Lucentis (Genentech) and Visudyne (Novartis). Genentech markets Lucentis within the United States only, and Novartis markets Lucentis outside the U.S. Novartis also markets Visudyne both in the U.S. and worldwide.

Visudyne is injected through a vein and then activated by light to stop damage caused by leakage from abnormal blood vessels forming in the inner back of the eye. Lucentis is injected into the eye to prevent new blood vessel growth and accompanying leakage that causes scarring and vision loss.

[Read more about FDA-approved macular degeneration treatments.]


National Eye Institute Seeks Volunteers for Major
Macular Degeneration Nutritional Study

BETHESDA, Md., October 2006 — The National Eye Institute is seeking 4,000 volunteers diagnosed with age-related macular degeneration (AMD) to participate in a major study that involves supplementing the diet with a specific combination of vitamins, minerals and oils from fish and vegetables.

The study, known as Age-Related Eye Disease Study (AREDS) II, involves supplementation with lutein and zeaxanthin derived from yellow plant pigment and with healthful omega 3 fatty acids such as those found in fish. [Read more about lutein and zeaxanthin and essential fatty acids regarding their role in eye health.]

Results released in 2001 from the NEI's original AREDS study demonstrated that antioxidants including beta-carotene, vitamins C and E, zinc and copper significantly reduced progression of early AMD to a more advanced and potentially blinding form of the eye disease, which can destroy central vision.

Volunteers for the new AREDS study are being enrolled at about 100 clinical sites nationwide. If you are between ages 50 and 85, have AMD and are interested in participating, call the NEI at 1-877-273-3780.


National Eye Institute Launches Study Comparing
Lucentis and Avastin for AMD

BETHESDA, Md., October 2006 — A new multicenter clinical trial will be funded to compare outcomes of treatments using Lucentis and Avastin for advanced macular degeneration (AMD), National Eye Institute officials in Bethesda, Md. announced.

Both drugs are produced by Genentech Inc. (San Francisco). Avastin is approved by the U.S. Food and Drug Administration for treatment of colorectal cancer, and Lucentis, which is far more expensive, was approved earlier in 2006 specifically for treatment of macular degeneration.

Both drugs act to prevent abnormal growth of blood vessels (angiogenesis). In advanced macular degeneration, abnormal blood vessel growth in the inner back of the eye (retina) can cause blindness.

Wet macular degeneration involves abnormal blood vessel growth in the back of the eye

Abnormal blood vessel growth in the inner back of the eye (retina) can cause blindness from macular degeneration. Photo courtesy of National Eye Institute, National Institutes of Health.
 

Prior to the Lucentis approval, many eye doctors were using Avastin off label to treat age related macular degeneration patients. Researchers (see news brief below) say Avastin costs less than $150 per treatment, compared with $2,000 per treatment for Lucentis.

Some news accounts note that Genentech Inc. could be harmed financially because of the threat to almost $1 billion in annual Lucentis sales if Avastin is found to be as effective as Lucentis for treatment of macular degeneration. Genentech made a considerable investment to fund research and studies leading to approval of Lucentis specifically as a macular degeneration treatment.

But some eye doctors say Avastin represents a much cheaper alternative for low income patients unable to access proper treatments for macular degeneration because of expense. Genentech officials have told news reporters that the company has a free drug program available for patients who aren't covered by health insurance.

[Read more about the Lucentis Vs. Avastin debate.]
 

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Bothered by blurry vision? New Blur Relief eye drops naturally refresh dry, irritated eyes

Tears Again Hydrate gels contain omega-3 fatty acids to treat dry eyes


 

Lucentis More Likely To Help AMD Patients With Early Vision Loss

MIAMI, October 2006 — People with early vision loss from age-related macular degeneration (AMD) are much more likely to benefit from a new U.S. Food and Drug Administration-approved therapy, Lucentis (Genentech Inc.), than those who have had vision loss for more than a year, according to study results published in the Oct. 5, 2006 issue of the New England Journal of Medicine.

More than 40 percent of participants with the more damaging, "wet" form of macular degeneration who received Lucentis treatments during the study had 20/40 or better vision after two years compared with only 6 percent in a control group, said study lead author Philip J. Rosenfeld, MD, PhD, ophthalmology professor at Miami's Bascom Palmer Eye Institute.

"It should be emphasized that ranibizumab (Lucentis) is not for everyone with wet AMD, and if the vision loss has been present for a year or longer, it is very unlikely ranibizumab will have any benefit," Rosenfeld said in the report. "There's a window of opportunity when ranibizumab can be effective. And when used within that window, it seems likely that ranibizumab can prevent blindness in the majority of patients with wet AMD, and even some spectacular vision improvements are observed."

An editorial published with study results notes that a form of the same drug, bevacizumab (Avastin), costs less than $150 per treatment compared with $2,000 per treatment for Lucentis. The editorial, authored by Howard Hughes Medical Institute investigator Edwin M. Stone, MD, PhD, of the University of Iowa, notes that "tens of thousands" of doses of the colorectal cancer drug, Avastin, were given off label to macular degeneration patients before Lucentis was approved.

Stone said it's important to now launch a study comparing the two drugs, particularly because Avastin (Genentech Inc.) is far more economical than Lucentis and potentially could make a difference for individuals who have limited incomes or inadequate health insurance coverage.


AMD Stem Cell Treatment Improves Vision in Rats

NEW ROCHELLE, N.Y., September 2006 — Researchers say rats with potentially blinding eye disease similar to age-related macular degeneration (AMD) in humans recovered at least some visual function after experimental treatment with embryonic stem cells.

The study reported in the fall 2006 issue of Cloning and Stem Cells, based in New Rochelle, N.Y., indicated that all animals treated with stem cells demonstrated improved visual performance. Rats with eye disease causing degenerative changes in the inner back of the eye (retina) similar to AMD recovered ability to see fine detail that was about 70 percent of what rats with normal vision can see.


People With Macular Degeneration May Experience Depression

TORONTO, September 2006 — People diagnosed with age-related macular degeneration (AMD) are three times more likely to experience severe depression, according to a report released in September 2006 from AMD Alliance International (AMDAI), based in Toronto.

The report says factors such as increased isolation and likelihood of injury due to visual impairment contribute to the likelihood that depression will develop among people who have the potentially blinding eye disease.

"AMD is no longer just about vision loss. It's also about mental health and quality of life, which is why AMD awareness and timely access to treatment and support services are essential," AMDAI Executive Director Wanda Hamilton said in a news release.


New Macular Degeneration Drug Can Be Used Like Eye Drops

SAN FRANCISCO, August 2006 — A new macular degeneration drug that can be applied as an eye drop has entered early stage clinical trials, according to an August 2006 news release from biopharmaceutical company Athengan (San Francisco).

The new drug, currently known as ATG003 (mecamylamine), has properties similar to several FDA-approved remedies in that it helps stop abnormal blood vessel growth that causes eye damage in more advanced forms of macular degeneration. Approved drugs such as Lucentis and Macugen now used for macular degeneration treatment must be injected into the eye.

ATG003 in early studies has been shown to have good penetration to the back of the eye when applied as an eye drop, Athengan co-founder M. (Ken) Kengatharan, PhD, said in a company news release.


Yellow Plant Pigment May Protect Eyes Against Macular Degeneration

MADISON, Wis., August 2006 — Yellow plant pigment found in foods such as green leafy vegetables, corn and squash may protect eyes against development and progression of the common and sometimes blinding eye disease of age-related macular degeneration (AMD), say University of Wisconsin researchers in Madison.

Wisconsin researchers reported in the August issue of Archives of Ophthalmology that yellow pigment found in a specific class of foods (carotenoids) known as lutein and zeaxanthin appears to help prevent eye cell damage from free radicals, groups of atoms that react with and break down normally healthy cells.

The Carotenoids in Age-Related Eye Disease Study (CAREDS) investigated effects of lutein and zeaxanthin in 1,787 women, aged 50-79, who participated in a large-scale Women's Health Initiative Study conducted in the late 1990s. The study involved taking blood samples to assess carotenoid levels and using color photographs of the inner back of the eye (retina) to monitor presence and progression of AMD.

More study is needed, but researchers noted an association between consistent, higher intakes of lutein and zeaxanthin and lower risk of intermediate-stage AMD in women younger than 75.

[Read more about the role of lutein and zeaxanthin in healthy vision.]


FDA Panel Votes Against Recommendation
of the Implantable Miniature Telescope

WASHINGTON, July 2006 — The Implantable Miniature Telescope (IMT), manufactured by VisionCare Ophthalmic Technologies Inc. (Saratoga, Calif.), did not prevail in a 10-3 vote by the FDA's Ophthalmic Devices Panel. Without recommendation by the panel, the FDA typically does not approve such devices.

In clinical trials of the IMT, 141 of 193 patients who received the device had improved distance and near visual acuity (10 patients reported a loss in acuity). But the FDA panel cited safety concerns: the higher than normal rate of cell loss in the cornea, which can in some cases require device removal and a corneal transplant, was not adequately analyzed, said the panel, so patient risk couldn't be determined. Also there were questions about effectiveness.

[Read more about investigational treatments for age-related macular degeneration.]


Eat Fish and Don't Smoke To Avoid Macular Degeneration

BOSTON, July 2006 — A study of elderly male twins has shown that eating foods rich in beneficial omega-3 fatty acids, such as those found in fish, could help reduce chances of developing the potentially blinding eye disease of age-related macular degeneration (AMD).

The same study conducted by researchers at the Massachusetts Eye and Ear Infirmary and Department of Biostatistics at Harvard Medical School also revealed that both current and past smokers were almost twice as likely to develop AMD, compared with non-smokers.

"This study of twins provides further evidence that cigarette smoking increases risk, while fish consumption and omega-3 fatty acid intake reduce risk of AMD," said associate professor of ophthalmology Johanna M. Seddon, MD, who also directs the infirmary's epidemiology unit.

Results of the study involving 681 male twins from the National Academy of Sciences - National Research Council World War II Veteran Twin Registry were published in the July 2006 issue of Archives of Ophthalmology.

[See also our nutrition article on essential fatty acids, including omega-3.]


Lucentis Receives FDA Approval for AMD Treatment

WASHINGTON, June 30, 2006 — The U.S. Food and Drug Administration in late June 2006 announced approval of Lucentis (Genentech Inc., San Francisco), a major new drug for treatment of advanced, age-related macular degeneration (AMD) that potentially can cause permanent loss of central vision.

In FDA clinical trials leading up to the approval, Lucentis was found to maintain vision in 95 percent of people receiving regular injections of the drug. Vision was actually improved in one-third of people who received Lucentis treatments, a significant finding for an eye disease that to-date has had no known cure. Lucentis is a treatment for the "wet" form of AMD, caused by abnormal blood vessel growth in the inner back of the eye (retina) where vision processing occurs.

Genentech announced in San Francisco that shipments of Lucentis for treatment of macular degeneration patients would begin June 30, 2006, the day of the FDA approval.

"In my opinion, the Lucentis approval stands out as one of the most important medical developments in ophthalmology during my 25 years in the field because it has the potential to reverse vision loss associated with wet AMD," American Society of Retina Specialists President Eugene de Juan, MD, said in a Genentech news release.


Unhealthy Carbs Could Boost Risk of Macular Degeneration

BOSTON, June 2006 — A diet higher in potentially unhealthy carbohydrates found in sources such as refined, white flour and sweet desserts could boost risks of developing age-related macular degeneration causing central vision loss, say Tufts University researchers in Boston.

In a study reported in the April 2006 issue of the American Journal of Clinical Nutrition, researchers from the Tufts University Laboratory for Nutrition and Vision Research examined eyes of 500 women between the ages of 53 and 73. The diets of study participants also were assessed in questionnaires administered at intervals during a 10-year period preceding the eye examinations.

Findings indicate that macular degeneration was found more frequently in women who favored less healthy carbohydrates, which can cause artificial spikes in blood sugar. Women who ate healthier carbohydrates such as high-fiber fruits and vegetables were less likely to develop the eye disease.

"...The types of carbohydrates being consumed were more important than the absolute amount," said study senior author and laboratory director Allen Taylor, PhD.

Taylor cautioned that more research is needed before a definite link can be shown between consumption of less healthy carbohydrates and development of macular degeneration.

[Read more about vision and nutrition.]


AMD Monitoring May Reduce Need for Additional Lucentis Injections

MIAMI, May 2006 — New study results indicate that patients with the "wet" or more vision-threatening form of macular degeneration (AMD) may need fewer drug injections into the eye, if their progress is carefully monitored with advanced imaging devices.

A technique for viewing cross-sectional, back interior structures of the eye, known as Optical Coherence Tomography (OCT), was used to monitor 40 AMD patients receiving injections of the investigational drug Lucentis (Genentech Inc.) at the University of Miami's Bascom Palmer Eye Institute.

In early May 2006, researchers reported one-year results showing that this type of monitoring of AMD patients can reduce needed drug injections to an average of only five or six annually. The need for additional or fewer injections than the average varied widely, depending on the individual patient's progress.

"By using OCT in this uncontrolled study, we were able to give fewer injections into the eye and observed vision improvement for most of our 40 patients," Bascom Palmer Eye Institute principal investigator Philip J. Rosenfeld, MD, PhD, said in a news release. Rosenfeld also is associate professor of ophthalmology at the institute.


AAO Urges Medicare Coverage of Avastin for Macular Degeneration

SAN FRANCISCO, April 2006 — Medicare should reimburse physicians using the colorectal cancer drug Avastin for treatment of age-related macular degeneration (AMD), the American Academy of Ophthalmology said in a formal request issued in late April 2006.

The AAO letter notes that many retinal specialists have been using Avastin "off label," which means the drug has not been specifically approved by the U.S. Food and Drug Administration as an AMD treatment. The AAO noted positive results and relative safety associated with injections of Avastin (bevacizumab) into the eye for treating AMD, a potentially blinding eye disease.

The AAO letter said a survey containing 289 responses from members of the American Society of Retinal Specialists revealed that 92 percent believe Avastin (Genentech Inc., San Francisco) was "somewhat better" or "much better" as an AMD therapy than current FDA-approved treatments.

"The Academy is concerned that, in spite of the current treatments available, fewer than 10 percent of patients have had significant improvement in visual acuity," said AAO Executive Vice President H. Dunbar Hoskins, MD. "Most patients continue to lose vision after one year of therapy."

A form of Avastin known as Lucentis (ranibizumab), specifically formulated as an AMD treatment, currently is undergoing late stage clinical studies. An FDA response to a request for approval of Lucentis should be issued no later than June 30, 2006, according to an AAO news release. [See news item about Lucentis below, or read another Avastin item.]


New Research Reinforces Link Between AMD and Genetics

NEW YORK CITY, March 2006 — New research reveals an even stronger connection than previously thought between inherited tendencies and development of the potentially blinding eye disease of age-related macular degeneration (AMD).

About 74 percent of people diagnosed with AMD have specific variants of one or both genes involved in immune responses known as Factors B and H, according to research led by Columbia University Medical Center investigators and published in the March 2006 issue of Nature Genetics.

"I am not aware of any other complex disorder where nearly 75 percent of genetic causality has been identified," said the study's lead author, Rando Allikmets, PhD.

Findings reinforce other research that had identified Factor H gene deficiencies as playing an important role in who develops macular degeneration, which affects more than 10 million U.S. residents. (See below: AMD news item on gene deficiencies)


New Discovery Explains Progression of Macular Degeneration

LEXINGTON, Ky., February 2006 — Recent discoveries about how the potentially blinding eye disease of macular degeneration (AMD) progresses into its most damaging form could have major implications for patient screening and future treatments, according to a University of Kentucky study.

Macular degeneration in its early stages can be detected when yellowish deposits known as drusen begin to form underneath the eye's inner back layer (retina) where images are processed. About 15 million U.S. residents have been diagnosed with early stage macular degeneration, known as the "dry" form.

A study published in the February 2006 issue of Proceedings of the National Academy of Sciences notes that certain components of drusen in early stage macular degeneration can be both indicators and causes of progression to the late stage or "wet" form of AMD, which occurs in up to 20 percent of cases. Abnormal blood vessel growth and leakage in the eye's retinal area cause the "wet" form of AMD.

The new discovery about how AMD progresses could help with screening patients at risk of developing advanced macular degeneration. Researchers also say laboratory tests now are aimed at investigating substances that might stop progression of macular degeneration, based on this new understanding of how the "wet" form of AMD develops.


Lucentis Might Improve Vision in Macular Degeneration Patients

NEW YORK CITY, January 2006 — Vision was maintained or improved in about 95 percent of macular degeneration patients who completed the first year of a two-year clinical study using an investigational drug known as Lucentis (Genentech Inc., San Francisco).

Study results detailing Lucentis (ranibizumab) outcomes were announced in mid-January 2006 during the Macula 2006 medical symposium in New York City, sponsored by the Manhattan Eye, Ear & Throat Hospital. During the study, Lucentis was injected into the eye at monthly intervals to treat the "wet" form of macular degeneration or AMD that causes central vision loss.

Bolstered by similar positive clinical outcomes from other studies, Genentech announced in late 2005 that application had been made to the U.S. Food and Drug Administration for a priority review and potential approval for Lucentis that could occur within six months.

"Lucentis is the first investigational therapy that has shown improved vision, not just a slowing of vision loss, in patients with all types of wet AMD," said Peter K. Kaiser, MD, who directs the The Cleveland Clinic Cole Eye Institute Clinical Research Center. Kaiser presented Lucentis data during the Macula 2006 symposium. "As a result, physicians may be one step closer to being able to set a new expectation for the future treatment of this condition."

"Wet" macular degeneration causes central vision loss because of abnormal blood vessel growth and leakage within the inner back lining of the eye, where the retina processes images.

In recently announced study results, vision was maintained or improved in 95 percent of Lucentis patients. Only 64 percent of patients treated with the more traditional photodynamic therapy (PDT), in which a laser targets damaged eye tissue, maintained or improved vision in the study. With Lucentis, about 36 percent of patients receiving .3 mg and 40 percent of patients receiving .5 mg had improved vision, compared with only 6 percent of patients receiving PDT.

Lucentis is derived from Avastin (see news item below), an FDA-approved Genentech drug used as an anti-cancer treatment. While Avastin has been used off-label to treat macular degeneration, Lucentis is the only Genentech drug undergoing clinical trials specifically as a macular degeneration treatment. Both Lucentis and Avastin work by halting abnormal blood vessel growth (neovascularization) that is an underlying factor in both cancer and macular degeneration.


Could Wet Age-Related Macular Degeneration Be
Caused by Inflammation?

BOSTON, November 2005 — Researchers found the presence of Chlamydia pneumoniae, a bacterium linked to heart disease that can cause chronic inflammation, in the diseased eye tissue of five of nine people with the wet form of age-related macular degeneration (AMD). They did not find it in more than 20 people without AMD, which may help to prove the theory that AMD is caused by inflammation. Further studies are in progress to test this and related theories. The new research was reported in Graefe's Archive for Clinical and Experimental Ophthalmology.


Smoking Doubles Risk of AMD, Says British Study

LONDON, May 2005 — Smokers among approximately 4,000 people aged 75 and older were twice as likely to have age-related macular degeneration than those who didn't smoke, says a study published in the British Journal of Ophthalmology. But the people who had quit smoking more than 20 years before had no higher risk for AMD than the non-smokers.

Smoking, alcohol consumption and cardiovascular disease incidence were all examined in the study. The researchers concluded that smoking could be linked to up to 30,000 cases of AMD in Britain and that the risk of losing one's vision should be added to the warnings about of health problems that appear on cigarette packages.


Gene Deficiency May Cause Many Cases of Macular Degeneration

DURHAM, N.C., March 2005 — A recently identified gene deficiency could be the underlying cause of almost half of all cases of the potentially blinding disease of age-related macular degeneration, Duke University Medical Center researchers said in March 2005.

Researchers say up to 15 million U.S. residents have some form of macular degeneration, the main cause of blindness in the elderly.

"Macular degeneration is an important cause of blindness and loss of independence in the elderly," said Margaret Pericak-Vance, PhD, who directs the Duke Center for Human Genetics. "This gene opens the door to a whole new understanding of the factors that contribute to this disease."

Pericak-Vance is senior author of the study report that discusses isolation of the responsible variant of a gene, complement factor H (CFH), from analysis conducted at Duke University Medical Center in Durham, N.C. and at Vanderbilt University Medical Center in Nashville, Tenn. Study results were published in Science Magazine.

The study was conducted by screening 189 families and examining 495 individuals who have macular degeneration, according to the Duke University news release.


Avastin May Improve Vision for Macular Degeneration
Patients Within One Week

MIAMI, March 2005 — Early study results indicate that a potential new age-related macular degeneration (AMD) therapy may improve vision within one week of injection, researchers announced at the Macula Society meeting of international retinal specialists.

Avastin, the drug used in initial studies, works by inhibiting growth of abnormal blood vessels in the back inner part of the eye (retina), a condition that occurs in the "wet" form of AMD. Researchers at the University of Miami's Bascom Palmer Eye Institute said Avastin substantially reduced blood vessel leakage contributing to vision loss.M.

A larger study is needed to determine if benefits of Avastin as a macular degeneration therapy outweigh risks, said Philip J. Rosenfeld, MD, PhD, associate professor of ophthalmology at the institute.

Avastin has effects similar to Macugen, which received FDA approval in December 2004. Both drugs target a specific type of protein thought to cause abnormal blood vessel growth. But while Macugen is injected directly into the eyes, Avastin is administered by intravenous injection (IV). Avastin currently has FDA approval for treatment of colorectal cancer, but not for macular degeneration.

The FDA has issued a caution that Avastin, when used to treat cancer patients, has been shown to increase risk of stroke and heart attack.


FDA Grants Priority Review for Retaane for Wet
Age-Related Macular Degeneration

FORT WORTH, Texas, February 2005 — The U.S. Food and Drug Administration accepted the New Drug Application for Retaane, a drug that Alcon, Inc. is developing to inhibit angiogenesis, or the abnormal growth of blood vessels in the back of the eye.

Retaane is administered onto the outer surface of the back of the eye at six-month intervals. It is designed to prevent the weakening of blood vessel walls to reduce the migration of cells that leads to the abnormal blood vessels forming. With the priority review designation, an FDA decision on whether to approve the drug could come in May 2005.


Program Helps Macular Degeneration Patients Improve Mood
and Function, Plus Avoid Depression

SAN DIEGO, January 2005 — A study found that a 12-hour self-management program for people with advanced age-related macular degeneration helped improve their mood and their ability to cope with vision loss. And over time, the program decreased the development of clinical depression in the study group, compared with the control group.

The 12-hour session educated participants about macular degeneration and low vision aids, allowed them to discuss the problems they experience in their daily lives because of the disease and its associated vision loss and strove to encourage a more hopeful, less helpless attitude toward their situation. The program was designed by the University of California, San Diego Shiley Eye Center; study results were written by Barbara Brody, M.P.H., et al. and published in the January 2005 Archives of Ophthalmology.


Call for Patients: Theragenics Corporation Holds Clinical Trials
for New Macular Degeneration Therapy

BUFORD, Ga., December 2004 — Enrollment is underway for a new clinical trial for the treatment of wet (exudative) age-related macular degeneration (AMD). The trial is sponsored by Theragenics Corporation and will investigate the safety and feasibility of using the TheraSight™ Ocular Brachytherapy System for treatment of sub-foveal choroidal neovascularization associated with wet AMD. The one-time brachytherapy treatment compares three doses of radiation using a group of 30 patients and six clinical sites. Contact Theragenics Corporation (1-877-960-1234) for further information on trial centers and eligibility criteria.


FDA Approves Macugen, a New Treatment for
Wet Age-Related Macular Degeneration

NEW YORK., December 2004 — Macugen (pegaptanib sodium injection) has received FDA approval and will be distributed by Eyetech and Pfizer for treatment of neovascular AMD — the wet form of age-related macular degeneration.

Macugen is injected once every six weeks. It targets vascular endothelial growth factor (VEGF), a protein that triggers the abnormal blood vessel growth and leakage that lead to central vision loss in people with wet AMD. Such vision loss severely affects a person's ability to live independently, since it can make driving, reading and recognizing faces difficult and eventually impossible.

In the FDA clinical trials, Macugen helped limit the progression to legal blindness by 50 percent compared with controls. And two-year clinical data showed a continued treatment benefit. The treatment will become available in the first quarter of 2005.


This Month FDA to Review Eyetech Pharmaceuticals'
and Pfizer's New Drug Application for AMD Treatment

NEW YORK, August 2004 — The FDA has accepted a New Drug Application (NDA) for Macugen, for treatment of age-related macular degeneration (AMD), and granted Priority Review status to the NDA. The agency and its Dermatologic and Ophthalmic Drugs Advisory Committee will review Macugen on August 27.

Macugen targets a type of vascular endothelial growth factor (VEGF), a protein that encourages blood vessel growth in the eye, which is a hallmark of the wet form of age-related macular degeneration. The therapy uses a molecule that binds to the VEGF and inhibits it.

Macugen is injected into the eyes every few weeks, with patients receiving a local anesthesia. In clinical trials a small percentage of patients regained some lost vision; a larger percentage showed a slower rate of vision loss than in untreated AMD patients. Macugen is being developed under a partnership between Eyetech Pharmaceuticals and Pfizer.


Aspirin and Statins Reduce Risk of Vision Loss
with Age-Related Macular Degeneration

SAN FRANCISCO, May 2004 — Researchers studied the use of statins, which are used to lower cholesterol, and aspirin among more than 300 seniors with age-related macular degeneration (AMD). Those who were taking statins were only half as liable to develop the more serious form of AMD, the wet form, than those who were not taking them. And those who were taking aspirin were 40 percent less liable to develop the condition.

The wet form of AMD is characterized by abnormal new blood vessel growth, called choroidal neovascularization or CNV. It is this blood vessel growth that was seemingly inhibited by statins and aspirin. The researchers speculated that the anti-inflammatory properties of the two drugs may be responsible for the effect.

Another significant finding of the study was that CNV development is more common with smokers, which seems to confirm earlier research (see below). The study was done at University of California - San Francisco and published in the April issue of the American Journal of Ophthalmology.


Smoking Increases Risk of Wet Age-Related Macular Degeneration

BOSTON, April 2004 — Smoking cigarettes increases the risk of developing the wet form of age-related macular degeneration by 2 percent, says a study published in the April issue of Archives of Ophthalmology. The study involved 73 elderly discordant sibling pairs in which one sibling had wet AMD in at least one eye and the other (older and past the diagnosis age of the other sibling) had normal eyes.

For each pack year of cigarettes smoked, the risk of AMD was slightly increased. Other risk factors were found as well — high blood pressure, high levels of alcohol consumption — but these were not statistically significant. The research was conducted at the Massachusetts Eye and Ear Infirmary.


Protein Linked to Heart Disease Also a Risk Factor for AMD

BOSTON, February 2004 — C-reactive protein, whose elevated levels in the blood can indicate heart disease and stroke, also increases the risk of age-related macular degeneration, according to a study published in the Journal of the American Medical Association. Dr. Johanna Seddon, an eye surgeon at Massachusetts Eye and Ear Infirmary, plans another study to see if the protein, which is an inflammatory marker, actually causes AMD. It is too early for conclusions, but other evidence has been mounting that people who are prone to cardiovascular disease are also prone to AMD.


Two Investigational AMD Drugs Show Promising Results

PLYMOUTH MEETING, Pa.; FORT WORTH, Texas, September 2003 — Two investigational drugs, squalamine and anecortave acetate, have shown promising study results in treating the wet form of age-related macular degeneration.

The squalamine study followed 40 patients, 64 percent of whom had preserved vision two months after treatment and 33 percent of whom had improved vision. Genaera Corporation, which makes squalamine and conducted the study, plans to release four-month data later this year.

Alcon, which makes anecortave acetate under the name Retaane, has been studying long-term use of the drug. Fifty-five patients continued the study through 24 months; 73 percent of the Retaane-treated patients had stable or improved vision, compared with 47 percent of the placebo group. The next phase of the trial will compare Retaane with Visudyne photodynamic therapy.


Clinical Trial for a New Type of AMD Treatment to Begin

WATERTOWN, Mass., August 2003 — Researchers at The Johns Hopkins University School of Medicine are about to begin a Phase I/II clinical trial of a drug that targets the abnormal blood vessels associated with the wet form of age-related macular degeneration. The drug, called Combretastatin A4 Prodrug, appears to prevent choroidal neovascularization, as well as to promote its regression.

Enrollment in the study is currently going on at The Johns Hopkins Wilmer Eye Institute in Baltimore.


Overweight Patients More Likely to Develop Advanced AMD

BOSTON, July 2003 — If you have macular degeneration (AMD), it pays to watch your weight. A recent study found that overweight AMD patients were about twice as likely to develop advanced AMD as their normal-weight counterparts. However, increased physical activity decreased their risk.

The study's researchers followed 261 AMD patients for an average follow-up time of 4.6 years. They measured the patients' body mass index (BMI), which is calculated by squaring your height in inches, dividing it into your weight, and multiplying the result by 703. A BMI of 18.5 to 24.9 is considered normal, 25 to 29.9 is overweight and 30 or more is obese. Overweight patients were 2.32 times as likely as normal-weight patients to develop advanced AMD, and obese ones were 2.35 times as likely. The researchers used geographic atrophy (degeneration) and neovascularization as measures of advanced AMD. Neovascularization causes central vision loss in AMD patients.

Patients who performed vigorous physical activity three times per week had a 25 percent decrease in their risk of developing advanced AMD, compared with participants who engaged in no vigorous physical activity.

The researchers reported the study in the June 2003 issue of Archives of Ophthalmology.


Supplement Improves Visual Function in AMD Patients

ROME, Italy, July 2003 — A supplement called Phototrop improves visual function in AMD patients, according to the results of a recent study. Phototrop contains acetyl-L-carnitine, concentrated omega-3 and coenzyme Q10.

The study was double-blind, meaning that neither the researchers nor the participants knew who was receiving the supplement and who was receiving a placebo.

Phototrop is currently not available in the United States, but its manufacturer is looking into U.S. distribution.


New Test Detects Macular Changes Better Than Amsler Grid

TEL-AVIV, Israel, June 2003 — A new test detects macular changes in macular degeneration (AMD) patients better than the Amsler grid, a recent study found.

Doctors currently use the Amsler grid to detect macular changes; it's simply a grid of horizontal and vertical lines with a dot to focus on in the middle. Patients look at it one eye at a time and note any lines that appear broken, bent, wavy or blurry.

The new test, called the Macular Computerized Psychophysical Test (MCPT), involves flashing a virtual line of white dots on a black background across different spots on the macula.

The study included 108 AMD patients and 51 people without retinal disease. The AMD patients included 32 with choroidal neovascularization (CNV), 23 with geographic atrophy (GA), 35 with high-risk characteristics (HRC) and 18 with early AMD who did not have high-risk characteristics. Researchers checked for macular changes in all 159 people with both the MCPT and the Amsler grid. The MCPT was more likely to detect macular changes than the Amsler grid:

Study Results: Percentages Found Positive for Macular Changes
Retinal DiseaseMCPTAmsler Grid
Choroidal neovascularization94%34%
Geographic atrophy91%30%
High-risk characteristics80%9%
Early age-related macular degeneration with no high-risk characteristics44%17%
No retinal disease6%2%

The researchers, who reported their results in the May 2003 issue of Ophthalmology, said that studies are underway to see if the MCPT could be used in the home for early detection of CNV.


Visudyne More Effective Than Placebo

FORT LAUDERDALE, Fla., June 2003 — Visudyne, a drug used to treat a subgroup of macular degeneration patients with leaky blood vessels that are defined as "predominantly classic," has proved effective in another subgroup as well, a recent study found. Researchers found that among those with "minimally classic" leakage, Visudyne-treated eyes lost less of their vision after 12 months than those receiving a placebo.

The researchers presented their results at the annual meeting of the Association for Research in Vision and Ophthalmology. They had obtained similar results at the six-month marker of the study.

Back to current macular degeneration news.

[Page updated January 2008]

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