Sirolimus for Advanced Age-Related Macular Degeneration
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
This study will determine whether a drug called sirolimus is safe to give to people with
geographic atrophy (GA) and if it can help preserve vision in patients. GA is an advanced
form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part
of the retina at the back of the eye needed for sharp, clear vision. There are two types of
AMD, wet and dry. In dry AMD, cells in the macula die.
GA may be partially caused by inflammation. Sirolimus helps prevent inflammation and
therefore may help people with GA. Researchers want to see whether sirolimus can help prevent
vision loss in people with GA.
People at least 56 years of age who have GA related to AMD in both eyes may be eligible for
this study.
This study requires at least 8 visits to the National Eye Institute over 1 year. Study visits
will be every 2 months for 1 year.
Participants will undergo the following procedures:
- Participants will be screened with a medical history and physical exam. They will also
have blood and urine tests, and eye exams. One eye will be selected as the study eye to
receive the sirolimus injections.
- Participants will have a sirolimus injection into the study eye at the first visit and
every 2 months thereafter unless contraindicated. There will be a follow-up eye exam 1
month after the first injection.