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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01319487
The ClinicalTrials.gov registry entry for NCT01319487 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (93% lower). The listed sponsor is Fovea Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.