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NCT01319487 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy
A Phase 2 study of Diabetic Macular Edema, sponsored by Fovea Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 267
- Enrollment target
- 20
- Study locations
NCT01319487: Completed Phase 2 study of Diabetic Macular Edema, sponsored by Fovea Pharmaceuticals.
NCT01319487 is a Phase 2 study of Diabetic Macular Edema that has completed, run by Fovea Pharmaceuticals. The registered enrollment target is 267 participants, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319487, a Phase 2 study of Diabetic Macular Edema, has completed, sponsored by Fovea Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 267 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.
Conditions Studied
Interventions
- DRUG 2304 Eye Drops High Dose
- DRUG 2304 Eye Drops Low Dose
- DRUG Placebo Eye Drops
Study Locations (20)
Other
- Center 2003 - Chatswood
- Center 2002 - Melbourne
- Center 2004 - Murdoch
- Center 2001 - Sydney
- Center 1302 - Antwerp
- Center 1301 - Brussels
Massachusetts
- Center 1101 - Boston
- Center 1109 - Boston
- Center 1111 - Boston
Arizona
- Center 1115 - Phoenix
- Center 1116 - Phoenix
Florida
- Center 1108 - Fort Myers
Illinois
- Center 1106 - Chicago
Indiana
- Center 1105 - Indianapolis
Michigan
- Center 1114 - Traverse
New Jersey
- Center 1112 - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT01319487 record still lists
NCT01319487 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which 2304 Eye Drops High Dose is the first listed.
NCT01319487 names 20 study sites across 12 states, led by Other, Massachusetts, Arizona.
Frequently Asked Questions
What is clinical trial NCT01319487 about?
NCT01319487 is a clinical study titled "Safety and Efficacy Study of Topical Administration of FOV2304 (High Dose or Low Dose) for the Treatment of Center-involving Clinically Significant Macular Edema Associated With Diabetic Retinopathy". The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.
What is the current status of trial NCT01319487?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 267 participants. The study started on 2011-05. Estimated completion is 2012-06.
What conditions does trial NCT01319487 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT01319487?
The interventions under investigation include: 2304 Eye Drops High Dose (DRUG), 2304 Eye Drops Low Dose (DRUG), Placebo Eye Drops (DRUG).
Who is sponsoring clinical trial NCT01319487?
This trial is sponsored by Fovea Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01319487 being conducted?
This trial has 20 study locations across Arizona, Florida, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
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 NCT01319487's enrollment target sits among peer trials
267 17th of 63 higher than 47 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema 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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