Macular Degeneration News

Trans Fats May Increase Macular Degeneration Risk

MELBOURNE, Australia, June 2009 — Eating higher amounts of trans-unsaturated fats is associated with increased incidence of the vision-destroying disease age-related macular degeneration (AMD), says a recent study.

From 2003 to 2006, researchers checked macula photographs of 6,734 participants' eyes for signs of early and late AMD. Then they compared the evaluations with nutrient intake information supplied by the participants.

Late AMD risk was higher in people who ate a lot of trans-unsaturated fats. But eating fatty acids and olive oil seemed to reduce the risk of AMD. Fish, total fat, butter and margarine did not show significant associations with AMD.

Trans-unsaturated fats are a known cause of heart disease. They are hardened fats that raise levels of bad cholesterol (LDL) and lower levels of good cholesterol (HDL). Doctors recommend that people avoid their consumption altogether, and they are gradually disappearing from processed foods.

The study report appeared recently in Archives of Ophthalmology.

Study Supports Injections of Anti-VEGF in Both Eyes on Same Day

FORT LAUDERDALE, Fla., May 2009 — With advanced macular degeneration in both eyes, people who need injections often have the extra burden of undergoing an injection in one eye only to be told they need to return to the clinic on another day for an injection in the second eye.

This is a problem particularly for those who live far from the clinic or who must rely on others for transportation.

So why is it done this way? Most eye doctors are reluctant to perform an invasive procedure on both eyes during the same visit. If anything goes wrong, then the patient risks having a problem in both eyes instead of just one.

But a study that examined results from 102 people who had received injections in both eyes (bilateral) and 102 who had received unilateral injections of anti-VEGF (either bevacizumab or ranibizumab) for macular degeneration found no difference in risk between the two methods.

The bilateral injections were done during the same visit, but separate trays of sterile instruments were used along with drugs from different manufacturer lots. So even if one eye developed infection or suffered an allergic reaction from the instruments or drugs, chances were that the other eye would not.

The study results were presented at the 2009 annual meeting of the Association for Research in Vision and Ophthalmology.

Macular Degeneration Cases Expected to Double by 2050

RESEARCH TRIANGLE PARK, N.C., April 2009 — Researchers predict that the number of people with age-related macular degeneration (AMD) in the United States will double by 2050 to more than 17.8 million. This is largely influenced by the baby boomer generation reaching retirement age, as the incidence rate increases from 1 percent for people 60 and younger to more than 5 percent for those 80 and older.

Without treatment, approximately 1.6 million AMD cases in 2050 would result in visual impairment and blindness; but existing treatments could reduce the number by 35 percent. Current treatments include vitamin prophylactic therapy (meaning, preventive vitamin use, which costs only about $100 per patient annually) and anti-vascular endothelial growth factor (anti-VEGF) injections.

The study found that vitamin prophylactic therapy, which slows the progression of AMD, alone could reduce visual impairment and blindness by 23 percent if used universally among early AMD patients. The sole use of anti-VEGF injections, which prevents the growth of blood vessels in the eye, could reduce the number by 17 percent for those in an advanced stage of the disease.

The study's lead author, David Rein, PhD, from RTI International, acknowledged that medical technologies are changing rapidly, as no treatments for AMD existed 10 years ago. Future advancements may lead to an even greater reduction in visual impairment and blindness from AMD, according to Dr. Rein.

The study was published in the April issue of Archives of Ophthalmology.

Implantable Eye Telescope Recommended for FDA Approval

SARATOGA, Calif., April 2009 — The Implantable Miniature Telescope (IMT), developed by VisionCare Ophthalmic Technologies, Inc., has received a unanimous recommendation for approval by the FDA Ophthalmic Devices Advisory Panel.

The panel recommended use of the IMT for end-stage age-related macular degeneration (AMD), with conditions including post-approval surveillance and labeling suggestions.

Photo: VisionCare Ophthalmic Technologies

The tiny IMT is implanted in one eye and is designed to send central vision images, magnified up to three times, over a wide area of the retina. It is the central part of the retina that macular degeneration damages most. By focusing images on other, healthier areas of the retina, the IMT can reduce the central "blind spot" that impairs vision in an AMD patient.

The eye without the IMT provides peripheral vision, which AMD doesn't affect as much. This provides the patient with mobility and navigation.

Usually FDA approval follows on the heels of recommendations by the advisory panel.

Chronic Kidney Disease Linked to Macular Degeneration

MADISON, Wis., March 2009 — Chronic kidney disease and the presence of serum cystatin C (a marker for kidney disease) have been associated with the incidence of age-related macular degeneration (AMD) in participants of the Beaver Dam Eye Study.

Serum cystatin C is found in retinal pigment epithelium cells. In this new analysis, its presence was associated with the incidence of early AMD and exudative AMD (in which abnormal blood vessels grow within the eye). Results were similar in both genders and increased with age.

Mild chronic kidney disease itself was associated with early AMD.

The researchers, from the University of Wisconsin School of Medicine and Public Health, said the underlying biological processes for these links are still unknown. The study was reported in the February issue of Archives of Ophthalmology.

The well-known Beaver Dam Eye Study began with 4,926 residents of Beaver Dam, Wis., in 1988, with follow-up examinations of participants every few years. Macular degeneration is but one of the many eye conditions that the study has measured.

Vitamin B Supplements May Help Prevent Macular Degeneration

BOSTON, March 2009 — Significant findings from a large study show that taking certain vitamin B supplements could reduce chances of developing age-related macular degeneration, which can be blinding in advanced forms.

Vitamin supplements including B-6, folic acid and B-12 reduced homocysteine levels in the blood, according to study results reported by Brigham and Women's Hospital researchers.

Some theories indicate that these higher homocysteine levels can cause heart disease, although previous studies have not confirmed this.

But in the recent study, researchers postulate that reducing homocysteine levels in the blood may help prevent diseases related to impaired function of small blood vessels — including macular degeneration and certain types of stroke.

The study was designed to follow more than 5,000 women who were 40 or older when the investigation began. These women also were considered at risk of developing cardiovascular disease.

After about seven years, researchers found that women who took vitamin B supplements had a 35 percent to 40 percent decreased risk of developing macular degeneration.

The study could not assess the value of vitamin B supplementation for preventing advanced forms of macular degeneration, because too few participants developed a progressive form of the eye disease.

Study results were reported in the February issue of Archives of Internal Medicine.

Avastin Causes Eye Inflammation Outbreak in Canada

SAN FRANCISCO, December 2008 — Off-label use of Avastin (bevacizumab) used to treat advanced or "wet" forms of macular degeneration (AMD) caused 36 recently reported adverse events, Genentech officials said in an advisory letter this month.

The letter to physicians says that 32 of the 36 events involved serious eye inflammation at four different centers in Canada. The source of the drug used for the Canadian eye injections was the same for 25 of the reported events: Avastin lot B3002B028. This lot was not distributed in the United States.

Adverse events in Canada were reported to Genentech's marketing partner, Roche, between Nov. 4 and Nov. 30.

Genentech officials said an internal quality inspection confirmed that the original source of the Avastin met all safety requirements for use as a cancer drug. The investigation also revealed no findings that would suggest the drug would cause eye inflammation.

Because Avastin is a cancer drug and not FDA-approved for treating macular degeneration, the drug must be repackaged by pharmacies outside supervision of Genentech before it can be injected into the eye.

A form of Avastin, Lucentis (ranibizumab), is FDA-approved and formulated specifically for treating macular degeneration. But many eye doctors use Avastin instead, because the cancer drug appears effective and is much cheaper than Lucentis.

A debate over use of Avastin versus Lucentis continues regarding which drug is more appropriate for treating advanced AMD when all factors, including safety and costs, are weighed.

Brain Compensates for Vision Loss in AMD

ATLANTA, November 2008 — Georgia Tech researchers have discovered that the brain reorganizes itself to compensate for vision loss caused by age-related macular degeneration (AMD).

AMD can lead to central vision loss. But researchers said concentration on seeing through the edges of the remaining visual field leads to accompanying changes in brain activity, as demonstrated by MRI imaging.

Image 1 demonstrates brain activity with a normal retina, and image 2 shows brain activity from someone compensating for central vision loss that can occur with AMD. (Georgia Tech)

"Our results show that the patient's behavior may be critical to get the brain to reorganize in response to disease," said assistant psychology professor Eric Schumacher.

The Georgia Tech study enlisted 13 volunteers who underwent visual tests to stimulate the peripheral parts of their vision.

By changing their behavior and concentrating on seeing in a different way, volunteers were able to increase activity in the same parts of the brain's visual cortex normally associated with good central vision.

This is the first study that directly demonstrates the brain's ability to reorganize itself due to specific behaviors when retinal disease is present, according to investigators.

Researchers said they now will investigate the possibility that specific low vision training can help the brain compensate for lost vision related to retinal diseases such as AMD.

Study results were reported in the December issue of Restorative Neurology and Neuroscience.

Diet and Blue Light Linked to "Wet" Macular Degeneration

LONDON, October 2008 — Too few antioxidants in the diet, combined with exposure to harmful "blue light" (HEV) rays, make you four times more likely to develop advanced or "wet" macular degeneration (AMD) later in life, according to a large European study.

Findings published in the October issue of Archives of Ophthalmology were based on a London School of Hygiene & Tropical Medicine analysis of 4,400 older adults. Results found that:

2,117 people did not have any form of macular degeneration.
2,182 people had early-stage or "dry" macular degeneration.
101 people had neovascular or "wet" macular degeneration involving new formation of abnormal blood vessels that can lead to blindness.

Blue light, known as high-energy visible light or HEV, generally was not linked to any kind of macular degeneration. But researchers said blue light exposure combined with low levels of antioxidants known to protect eyes against sun damage increased risks of neovascular AMD fourfold.

Researchers suggested that older individuals consume adequate levels of antioxidants including vitamin C and zinc, along with carotenoid-rich fruits and vegetables.

Sunglasses also were recommended to shield eyes against sun damage. Most sunglasses have at least some UV protection, but many do not protect against blue light.

Ask your eye doctor about which sunglasses you should use to block 100 percent UV rays and a high percentage of HEV or blue light rays.

Small Study Shows That Lucentis Beats Avastin for Treating AMD

MUNICH, August 2008 — Munich researchers say Lucentis demonstrated a slight advantage over Avastin when the drug was injected into the eyes of people who needed additional treatment for advanced or "wet" forms of macular degeneration (AMD).

The study involved 64 people who initially received treatment with Avastin, and then developed additional macular edema or swelling in the inner back of the eye (retina) that can occur with advanced macular degeneration.

Half of the people received additional treatment with Avastin, and the other half were treated with Lucentis. Both drugs are similar and marketed by the same company, Genentech. However, Avastin is a cancer drug and Lucentis is formulated and FDA-approved specifically for treating macular degeneration.

Because Lucentis is far more expensive than Avastin, many eye doctors choose to use Avastin off label as a cost-saving measure.

"We are of course aware that definite conclusions cannot be drawn and recommendations cannot be given based on our data, due to the small number of patients and the retrospective nature of our analysis," investigators said in an article published in the September issue of British Journal of Ophthalmology.

But researchers (from Ludwig-Maximilians-University Department of Ophthalmology in Munich) said both groups of people in the study were evenly matched, and results definitely point to the need for a large-scale comparison of the effectiveness of both drugs.

[Read more about the Lucentis vs. Avastin controversy.]

Alcon Terminates Study of Drug for Treating Macular Degeneration

HUENENBERG, Switzerland, July 2008 — Anecortave acetate (Retaane) has been withdrawn as a potential treatment for advanced or "wet" forms of macular degeneration (AMD) after Alcon officials evaluated two-year study results involving 2,546 people.

Alcon officials also ended other ongoing studies, after determining that the drug had failed to meet treatment objectives. Anecortave acetate was explored as a way to stop enzymes that allow growth of abnormal blood vessels causing vision loss in advanced AMD.

Meanwhile, studies will continue on the use of anecortave acetate for lowering high intraocular pressure associated with development of glaucoma.

Alcohol Consumption Ruled Out as Risk Factor for AMD

ROTTERDAM, June 2008 — A comprehensive study has ruled out alcohol consumption as a possible contributing factor to development of age-related macular degeneration (AMD), according to a report published in the June issue of Archives of Ophthalmology.

Investigators at Erasmus Medical Center in the Netherlands analyzed data from 4,229 people at risk of developing AMD, a sometimes blinding disease. The study looked at alcohol consumption habits and potential associations with development of macular degeneration, including different stages of the disease.

Of the individuals studied over an approximate eight-year time period, 519 developed early-stage macular degeneration and 81 were diagnosed with advanced and potentially blinding forms of the disease. The study was adjusted for other variables that might contribute to development of AMD such as age, sex, smoking and specific genetic factors.

Does Hormone Use Lower Risk of Advanced
Macular Degeneration in Women?

BOSTON, April 2008 — Declining levels of the hormone estrogen may contribute to development of advanced forms of age-related macular degeneration (AMD) in postmenopausal women, according to researchers at Brigham and Women's Hospital and Harvard Medical School.

A study found a 48 percent lower risk of developing advanced forms of macular degeneration among post-menopausal women who took estrogen as part of hormone replacement therapy. The risk was even lower for postmenopausal women who previously had taken oral contraceptives.

But in what researchers said was an unexpected finding, the risk of developing early forms of macular degeneration was 34 percent higher in women who, at the time of the study, used hormone replacement therapy. Women who had given birth had a 26 percent lower risk of developing early AMD. Past oral contraceptive use in this group was not a factor.

The study involved about 75,000 postmenopausal women who participated in the Nurses' Health Study. Between 1980 and 2002, 554 of the women developed early-stage macular degeneration, and 334 had late-stage AMD, which can cause loss of central vision.

Study results were published In the April issue of Archives of Ophthalmology.

Discovery May Lead to Therapies for "Dry" AMD

MONTREAL, February 2008 — Researchers in Montreal have identified an underlying cause of the "dry" form of age-related macular degeneration (AMD), a discovery that could lead to development of new therapies.

Sainte-Justine Hospital and Universite de Montreal scientists said they now have a better understanding of processes that cause accumulations of lipids (fats) in the inner back of the eye (retina), which can lead to eye damage associated with macular degeneration.

"This discovery brings us one step closer to treating dry AMD, which could significantly improve the quality of life of seniors who are most affected by this eye disease," said Universite de Montreal professor and study co-author Huy Ong, PhD.

Study results were published in the February issue of the medical journal PLoS Medicine.

African Americans May Have Less Risk for
Developing Macular Degeneration

BALTIMORE, February 2008 — African Americans may have less risk of developing advanced macular degeneration (AMD) than Caucasians, according to recent findings by Johns Hopkins School of Medicine scientists.

Early signs of AMD include formation of yellowish spots (drusen) in the inner back of the eye (retina), where vision processing occurs. In a study involving 2,520 participants of average ages of 73.5 years, researchers found that larger drusen and those closer to the eye's center were more likely to occur in Caucasians than in African Americans.

Study authors concluded that more Caucasians than African Americans were likely to develop advanced and potentially blinding forms of macular degeneration. Researchers said more research is needed to determine why African Americans are less likely to have significant degenerative changes associated with AMD, such as those that occur in central portions of the retina.

Smoking Increases Macular Degeneration Risk by Nearly 50 Percent

BEAVER DAM, Wis., January 2008 — Smoking boosts risks of developing age-related macular degeneration (AMD) by nearly 50 percent, reveals a recent analysis of about 3,500 Beaver Dam, Wis. residents undergoing eye-related studies since 1987. The finding was reported in the January issue of Archives of Ophthalmology.

Study results also show that, of people who have macular degeneration, smokers on average were more likely to develop the eye disease at a younger age:

Current smokers (69.2 years)
Former smokers (72.3 years)
Non-smokers who have never smoked (74.4 years)

Researchers noted that it's difficult in modern times to assess eye damage caused by secondary exposure to smoke, partly because of new laws that now restrict smoking in public areas.

British Agency Reverses Stand on Restricting Lucentis for AMD

LONDON, January 2008 — A British health advisory agency has reversed an earlier cost-saving proposal that allows government reimbursement for Lucentis treatments only for the second eye of individuals diagnosed with advanced or "wet" age-related macular degeneration (AMD), which can cause blindness.

The National Institute for Health and Clinical Excellence (NICE) has issued a revised proposal, with "draft" status ending Jan. 14, which would allow Lucentis to be injected in any affected eye of British citizens when treatments are capped at 14 per eye.

If additional treatments are needed, NICE officials say the Lucentis manufacturer (Genentech, San Francisco) has agreed to provide additional doses at no cost.

NICE officials say Lucentis is an effective though expensive drug capable of stabilizing vision loss in most people with advanced AMD. About 25 percent of affected eyes achieve vision improvement after regular Lucentis treatments, which cost more than $2,000 per dose.

In another recent development, Genentech announced that a much cheaper version of Lucentis, known as Avastin, will be sold directly to any physicians who choose to use the drug off-label for treating AMD. Avastin is not FDA-approved as an AMD treatment.

Late last year, Genentech made the controversial decision to cease selling Avastin directly to compounding pharmacies that had been repackaging the cancer drug for use as an AMD treatment.

In its recent announcement, Genentech said physicians choosing to use Avastin as an AMD treatment can purchase the drug directly and designate where they want it shipped — including to compounding pharmacies.