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 Disease | MCPT | Amsler Grid |
| Choroidal neovascularization | 94% | 34% |
| Geographic atrophy | 91% | 30% |
| High-risk characteristics | 80% | 9% |
| Early age-related macular degeneration with no high-risk characteristics | 44% | 17% |
| No retinal disease | 6% | 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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