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NCT01003691 · ClinicalTrials.gov registry record · Phase 1
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
A Phase 1 study of Eye Diseases and Macular Degeneration, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT01003691: Completed Phase 1 study of Eye Diseases and Macular Degeneration, sponsored by Pfizer.
NCT01003691 is a Phase 1 study of Eye Diseases and Macular Degeneration that has completed, run by Pfizer. The registered enrollment target is 24 participants, below the 741,302-participant average among 27 other Eye Diseases trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003691, a Phase 1 study of Eye Diseases and Macular Degeneration, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.
Primary Outcome
The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included seriou
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RN6G
Study Locations (20)
California
- Retinal Diagnostic Center - Campbell
- American Institute of Research (Administrative Only) - Los Gatos
- Neurology Center Rai Kumar - San Jose
- Harmeet Sachdev, MD, FAAN - San Jose
- Santa Clara Drug - San Jose
South Carolina
- Hawthorne Pharmacy - West Columbia
- Jay Markowitz and Associates - West Columbia
- Palmetto Retina Center, LLC - West Columbia
- South Carolina Neurological - West Columbia
Texas
- National Central Pharmacy - Abilene
- Abilene Surgery Center - Abilene
- Heart and Vascular Institute - Abilene
- Retina Research Institute of Texas - Abilene
Georgia
- Ranjit K. Sethi, MD, PC - Augusta
- Clinical Specialists, LLC - Augusta
- Southeast Retina Center, PC - Augusta
Florida
- Retina Associates of Florida, PA - Tampa
- Hoye's Pharmacy - Tampa
New York
- University of Rochester Medical Center - Rochester
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-08-05 |
| Est. Completion | 2013-04-19 |
| Phase | Phase 1 |
What the finished NCT01003691 record still lists
NCT01003691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 741,302-participant average among 27 other Eye Diseases trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Eye Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01003691 names 20 study sites across 6 states, led by California, South Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT01003691 about?
NCT01003691 is a clinical study titled "Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy". The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.
What is the current status of trial NCT01003691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-08-05. Estimated completion is 2013-04-19.
What conditions does trial NCT01003691 study?
This clinical trial studies the following conditions: Eye Diseases, Macular Degeneration, Retinal Degeneration, Age-related Maculopathy, Age-Related Maculopathies.
What interventions are being tested in trial NCT01003691?
The interventions under investigation include: Placebo (BIOLOGICAL), RN6G (BIOLOGICAL).
Who is sponsoring clinical trial NCT01003691?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01003691 being conducted?
This trial has 20 study locations across California, Florida, Georgia, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01003691's enrollment target sits among peer trials
24 24th of 27 higher than 4 of 27 other Eye Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eye Diseases 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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