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Macular Degeneration 101
Clinical Trials
New Treatments for Treatment of Age-Related Macular Degeneration
Updated: July 2008
There are many areas of exciting research addressing the prevention and treatment of AMD. As a service to our readers, we provide in this section information on current clinical trials for new treatments. The section will be expanded over time as more information becomes available.
Information for this section is compiled by Maureen G. Maguire, Ph.D., Director of the Center for Preventive Ophthalmology and Biostatistics, University of Pennsylvania.
OT-551 Eye Drops to Treat Geographic Atrophy (OMEGA)
Sponsor of Trial: Othera Pharmaceuticals
Treatment being tested: Anti-oxidant drug delivered through eye drops.
Status:
- Recruitment of patients began June 2007 and ended in February 2008.
- Patients need to have advanced “dry” AMD (geographic atrophy) in one eye or both eyes.
- Patients are assigned randomly to either a low dose of the drug in the eye drops, a high dose, or a drops without the drug.
- Follow-up for 2 years.
- Results expected in Spring 2010.
More Information:
Comparison of AMD Treatments Trials (CATT): Lucentis-Avastin Trial
Sponsor of Trial: National Eye Institute
Treatments being tested: Intravitreal injection of ranibizumab (Lucentis®) or of bevacizumab (Avastin®). Each drug blocks the action of vascular endothelial growth factor (VEGF) in patients who have neovascular (choroidal neovascularization, CNV) AMD. Patients are assigned randomly to 1 of 4 treatment groups:
- Lucentis® on a fixed schedule of once every four weeks
- Avastin® on a fixed schedule of once every four weeks
- Lucentis® on a variable schedule depending on the patient’s response to treatment
- Avastin® on a variable schedule depending on the patient’s response to treatment
Status:
- Recruitment in this Phase III clinical began in February 2008 and is ongoing
- Patients need to have “wet” AMD
- Follow-up visits every 28 days for 2 years
More Information:
- Many clinical centers nationally, listed on the following websites
- http://clinicaltrials.gov/ct2/show/NCT00593450
- http://www.nei.nih.gov/CATT
Implantable Miniature Telescope
Sponsor of Trial: Vision Care
Treatment being tested: A micro-sized precision telescope is implanted in the eye to project magnified images over a wide field of the retina. Patients undergo 3 months of vision training after surgery
Status:
- Fall 2005- Enrollment in Phase II/III (safety and efficacy) clinical trial began in January 2003; patients followed for 2 years.
- December 2007- Recruitment complete, awaiting results.
Patients must have untreatable central visual acuity loss in both eyes.
More Information:
- http://www.visioncareinc.net/technology.html
- Call Toll-free: (888)528-0006
Age-Related Eye Disease Study 2
Sponsor of Trial: National Eye Institute (NEI).
Treatment being tested: Dietary supplements containing either lutein/zeaxanthin, Omega-3 fatty acids, or both for the prevention of the development of late stage AMD and vision loss.
Status:
- Recruitment began September 2006
- Patients must have large drusen OR either choroidal neovascularization (CNV) or geographic atrophy in 1 eye
- Patients randomized to dietary supplements or placebo
- Patients followed for 5 years
- Many centers nationally
More Information:
- http://www.clinicaltrials.gov/ct2/show/NCT00345176
- http://www.areds2.org/
- http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120 (listing of clinical centers)
Radiation Treatment with Lucentis (CABERNET)
Sponsor of Trial: NeoVista, Inc.
Treatment being tested: Strontium90 Beta Radiation
Status:
- Recruitment of patients began June 2007
- Patients need to have choroidal neovascularization “wet” AMD
- Patients are assigned randomly to either Lucentis with radiation or to Lucentis alone
- Follow-up for 2 years
More Information:
Encapsulated Cell Technology (ECT) Implant for Dry AMD
Sponsor of Trial: Neurotech Pharmaceuticals
Treatment being tested: Implantation into the eye of a small capsule that releases ciliary neurotrophic factor (CNTF) to slow progression of atrophy.
Status:
- Recruitment completed, awaiting results
- For patients with visual acuity loss from advanced “dry” AMD (geographic atrophy)
- Phase II clinical trial started recruiting in January 2007 in 8 US centers
- Patients assigned randomly to receive an implant with active drug or simulation of surgery with no implantation
- Patients followed for 18 months
More Information:
Combination of Bevasiranib & Lucentis Therapy in Wet AMD (COBALT)
Sponsor of Trial: Opko Health, Inc.
Treatment being tested: Injection of a drug (bevasiranib) that decreases the production of vascular endothelial growth factor (VEGF).
Status:
- Recruitment started July 2007
- For patients with “wet” AMD (choroidal neovascularization)
- Phase III clinical trial at 26 centers nationally
- Patients assigned randomly to receive Lucentis every 4 weeks or 3 treatments of Lucentis followed by bevasiranib every 8 weeks or 3 treatments of Lucentis followed by bevasiranib every 12 weeks
- Patients followed for 14 months
More Information:
VEGF Trap for Choroidal Neovascularization (VIEW1 STUDY)
Sponsor of Trial: Regeneron Pharmaceutials and Bayer
Treatment being tested: Intravitreal injection of an agent (VEGF Trap) that blocks the action of vascular endothelial growth factor (VEGF) in patients who have neovascular (choroidal neovascularization, CNV).
Status:
- Phase III clinical trial started recruiting in August 2007
- Patients are assigned randomly to injections of either VEGF Trap or Lucentis (ranibizumab)
- Patients receive treatment for at least 1 year
More Information:
- http://www.clinicaltrials.gov/ct2/show/NCT00509795
- Email: VIEW1study@rtp.ppdi.com
Dr. Maureen Maguire received her Ph.D. in Biostatistics from the Bloomberg School of Public Health, Johns Hopkins University. Currently, she is the Carolyn F. Jones Professor of Ophthalmology, School of Medicine, University of Pennsylvania and director of the Center for Preventive Ophthalmology and Biostatistics. Although she has been involved in clinical research efforts in many areas of eye disease and health, she has concentrated in the area of prevention and treatment of age-related macular degeneration. She has held a leadership position in several multicenter clinical trials sponsored by the National Institutes of Health or industry.
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This animation shows the degenerative changes to the macula. A dark area, or black out, may appear in the center of vision, but peripheral vision often remains clear.