Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
This study examined whether the anti-inflammatory medicines infliximab, sirolimus or
daclizumab, when given with a participant's current therapies, would prevent the growth of
new blood vessels in the eye in participants with age-related macular degeneration (AMD).
Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible
for this study. Vision in the study eye was between 20/20 and 20/400.
Participants were randomly assigned to one of three treatments - infliximab, sirolimus, or
daclizumab - or to observation only. In addition, participants may have been treated by their
ophthalmologist as needed for their AMD.
Infliximab and daclizumab were given intravenously (through a vein); infusions were given at
enrollment in the study, then at 2 weeks, and then monthly.
Sirolimus was a pill that was taken every other day for the duration of the study. At 6
months, participants were evaluated to see whether continuing treatment would be beneficial.
In addition to treatment or observation, participants underwent the following procedures:
Physical examination at enrollment and 6 months.
Photographs of the back of the eye, fluorescein angiography, indocyanine green angiography
and measurement of retinal thickness at enrollment and months 1, 3 and 6.
- Fluorescein angiography evaluated the eye's blood vessels. A yellow dye was injected
into an arm vein and traveled to the blood vessels in the eyes. Pictures of the retina
were taken using a camera that flashed a blue light into the eye. The pictures show if
any dye has leaked from the vessels into the retina, indicating possible blood vessel
abnormality.
- Indocyanine green angiography identified feeder vessels that may have supplied abnormal
blood vessels. This procedure is similar to fluorescein angiography, but uses a green
dye and flashes an invisible light.
- Optical coherence tomography measures retinal thickness. This test shines a light into
the eye and produces cross-sectional pictures of the retina. These measurements are
repeated during the study to determine whether retinal thickening is getting better or
worse, or staying the same.
Tuberculin skin test and chest x-ray at enrollment and 6 months.
Blood tests at enrollment and months 1, 3 and 6.
Phase:
Phase 2
Details
Lead Sponsor:
National Eye Institute (NEI)
Treatments:
Daclizumab Everolimus Immunoglobulin G Infliximab Sirolimus