Palomid 529 in Patients With Neovascular Age-Related Macular Degeneration
Status:
Completed
Trial end date:
2012-09-20
Target enrollment:
Participant gender:
Summary
Background:
- Wet age-related macular degeneration (AMD) occurs when abnormal blood vessels grow in
the back of the eye, and leak blood and other fluids that damage the eye, produce
scarring, and lead to blindness. People diagnosed with wet AMD have increased production
of a body chemical called vascular endothelial growth factor (VEGF). VEGF is important
in the formation of blood vessels in the body, and decreasing the production of VEGF is
believed to help wet AMD patients by preventing or slowing the growth of the abnormal
blood vessels. Anti-VEGF drugs have been used to decrease the production of VEGF, but
some people do not respond completely to these drugs.
- A protein in the body called mTOR also plays a critical role in regulating how cells
divide and grow and obtain their blood supply. The experimental chemical Palomid 529
inhibits the production of mTOR. Researchers are interested in determining whether
Palomid 529 is safe and can help individuals with wet AMD who have not completely
responded to anti-VEGF treatments.
Objectives:
- To evaluate the safety and effectiveness of Palomid 529 as a treatment for wet age-related
macular degeneration in individuals who have not responded to standard anti-VEGF treatments.
Eligibility:
- Individuals with wet age-related macular degeneration in at least one eye that has not
responded to standard anti-VEGF treatments.
Design:
- Prior to the first visit, participants should have been seen at the National Eye
Institute clinic under a screening or teaching protocol, or NIH protocol 08-EI-0103,
High Speed Indocyanine Green Angiography Findings in Induction Regimen of Intravitreal
Ranibizumab Injection for Neovascular Age Related Macular Degeneration. One eye will be
designated as the study eye to receive the Palomid 529 treatment.
- Participants will have a full physical examination and medical history, a full eye
examination to evaluate eye health and vision, angiography to examine the blood vessels
in the eyes, and blood and urine tests during the study
- Participants will receive an injection of Palomid 529 into the study eye every 4 weeks
during the study, for a total of three injections. Participants may also receive
anti-VEGF injections such as ranibizumab (Lucentis ) or bevacizumab (Avastin ) in the
study eye 12 days before and 12 days after the Palomid 529 injection.
- Participants may have standard-of-care treatments for the non-study eye if it has wet
AMD as well, but may not receive experimental treatments in the non-study eye while they
are in this study.
- Participants will return for long-term follow-up examinations as directed by the study
researchers.