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NCT00931489 · ClinicalTrials.gov registry record · Phase 2
Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)
A Phase 2 study of Age-related Macular Degeneration, sponsored by Lawrence S. Morse, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
- 1
- Study location
NCT00931489: Completed Phase 2 study of Age-related Macular Degeneration, sponsored by Lawrence S. Morse, MD.
NCT00931489 is a Phase 2 study of Age-related Macular Degeneration that has completed, run by Lawrence S. Morse, MD. The registered enrollment target is 131 participants, below the 1,506-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00931489, a Phase 2 study of Age-related Macular Degeneration, has completed, sponsored by Lawrence S. Morse, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators hope to determine if "wet" AMD patients differ from patients with "dry" AMD or normal eyes in the production of anti-retinal pigment epithelium (anti-RPE) or anti-retinal antibody formation. To explain: the immune system can make antibodies that attack our own cells, specifically the RPE and the retina. Normally the RPE and retinal cells are ignored by the immune system, but when disease occurs, immune reactions can occur, making an autoantibody that can attack the patient's own cells and make things worse. This production of autoantibodies that react with our own RPE and retinal cells is what the investigators want to test in this proposal to see if they may contribute to, or are responsible for, a poor response to treatment. The investigators also want to know how those patients who initially respond to the standard-of-care treatment, ranibizumab injections, differ in the production of anti-RPE or anti-retinal antibody formation, from those patients who do not respond initially after 4 consecutive injections.
Primary Outcome
Blood samples were collected from all study participants at baseline and Western Blot analysis was performed to identify the presence of anti-retinal and anti-RPE antibodies. Presented are the number of subjects in which the presence of anti-retinal and anti-RPE antibodies (yes/no) were recorded by a masked observer.
Conditions Studied
Interventions
- DRUG ranibizumab (Lucentis(R))
Study Locations (1)
California
- University of California, Davis - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT00931489 record still lists
NCT00931489 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 1,506-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which ranibizumab (Lucentis(R)) is the first listed.
NCT00931489 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00931489 about?
NCT00931489 is a clinical study titled "Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)". The investigators hope to determine if "wet" AMD patients differ from patients with "dry" AMD or normal eyes in the production of anti-retinal pigment epithelium (anti-RPE) or anti-retinal antibody formation. To explain: the immune system can make antibodies that attack our own cells, specifically t...
What is the current status of trial NCT00931489?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2009-08. Estimated completion is 2014-06.
What conditions does trial NCT00931489 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT00931489?
The interventions under investigation include: ranibizumab (Lucentis(R)) (DRUG).
Who is sponsoring clinical trial NCT00931489?
This trial is sponsored by Lawrence S. Morse, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00931489 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00931489's enrollment target sits among peer trials
131 23rd of 74 higher than 52 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration 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.
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