Clinical Trials

New Treatments for Treatment of Age-Related Macular Degeneration

Updated: October 2009

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.

Lucentis: 2 Doses, Monthly or as Needed (HARBOR)

Sponsor of Trial: Genentech

Treatment being tested:  Injection into the eye of a drug (ranibizumab or Lucentis) that decreases the production of vascular endothelial growth factor (VEGF).  The drug given every month at 0.5mg per injection has been shown to be highly efficacious and is approved by the FDA for treatment or wet AMD.

Status:

  • Recruitment started April 2009
  • For patients with “wet” AMD (choroidal neovascularization)
  • Phase III clinical trial at 61 centers nationally
  • Patients assigned randomly to 1 of 4 treatment groups:

1)    Monthly injection of 0.5mg of ranibizumab
2)    Injection of 0.5mg of ranibizumab as needed
3)    Monthly injection of 2.0 mg of ranibizumab
4)    Injection of 2.0 mg of ranibizumab as needed
Patients followed for at least 12 months

More Information: http://clinicaltrials.gov/ct2/show/NCT00891735
Call: 888-662-6728

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 completed; results expected in early 2011
  • Patients need to have “wet” AMD
  • Follow-up visits every 28 days for 2 years

More Information:

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 completed, awaiting results
  • 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:

 

 

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:

 

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 and completed recruitment in September 2009. Awaiting results.
  • 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
  • Call 866-549-8429
  • 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.