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NCT00304954 · ClinicalTrials.gov registry record · Phase 2
Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00304954: Completed Phase 2 study, sponsored by National Eye Institute (NEI).
NCT00304954 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00304954, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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 pi
Interventions
- OTHER Observation
- DRUG Intravenous Daclizumab
- DRUG Intravenous Infliximab
- DRUG Oral Rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2006-02 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00304954 record still lists
NCT00304954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Observation is the first listed.
NCT00304954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00304954 about?
NCT00304954 is a clinical study titled "Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration". 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 ...
What is the current status of trial NCT00304954?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2006-02. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00304954?
The interventions under investigation include: Observation (OTHER), Intravenous Daclizumab (DRUG), Intravenous Infliximab (DRUG), Oral Rapamycin (DRUG).
Who is sponsoring clinical trial NCT00304954?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00304954's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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