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NCT01331005 · ClinicalTrials.gov registry record · Phase 2
NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)
A Phase 2 study of Diabetic Macular Edema, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 20
- Study locations
NCT01331005 is a Phase 2 study of Diabetic Macular Edema that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 125 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01331005, a Phase 2 study of Diabetic Macular Edema, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being conducted to assess the effects of topical nonsteroidal anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with non-central diabetic macular edema (DME). A secondary objective of this study is to assess the effects of topical NSAIDs on central subfield thickness and to compare the progression of non-central DME to central DME as determined by optical coherence tomography (OCT) and stereoscopic fundus photographs. Furthermore, this phase II study is being conducted (1) to determine whether the conduct of a phase III trial has merit based on an anatomic outcome, (2) to estimate recruitment potential of a phase III investigation, and (3) to provide information on outcome measures needed to design a phase III trial. The study is not designed to establish the efficacy of NSAIDs in the treatment of non- central DME.
Conditions Studied
Interventions
- DRUG nepafenac 0.1% drops
- OTHER Nepafenac Vehicle
Study Locations (20)
California
- Loma Linda University Health Care, Dept. of Ophthalmology - Loma Linda
- Southern California Desert Retina Consultants, MC - Palm Springs
- California Retina Consultants - Santa Barbara
- Bay Area Retina Associates - Walnut Creek
- Retinal Consultants of Southern California Medical Group, Inc. - Westlake Village
Florida
- Retina Consultants of Southwest Florida - Fort Myers
- Central Florida Retina Institute - Lakeland
Indiana
- Raj K. Maturi, M.D., P.C. - Indianapolis
- American Eye Institute - New Albany
Kentucky
- Retina and Vitreous Associates of Kentucky - Lexington
- Paducah Retinal Center - Paducah
Michigan
- Henry Ford Health System, Dept of Ophthalmology and Eye Care Services - Detroit
- Vitreo-Retinal Associates - Grand Rapids
Georgia
- Southeast Retina Center, P.C. - Augusta
Hawaii
- Retina Associates of Hawaii, Inc. - Honolulu
Iowa
- Wolfe Eye Clinic - West Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331005
The ClinicalTrials.gov registry entry for NCT01331005 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (97% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 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 2 interventions - of which nepafenac 0.1% drops is the first listed.
NCT01331005 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT01331005 about?
NCT01331005 is a clinical study titled "NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)". This study is being conducted to assess the effects of topical nonsteroidal anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with non-central diabetic macular edema (DME). A secondary objective of this study is to assess the effects of topical NSAIDs on central su...
What is the current status of trial NCT01331005?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2011-05. Estimated completion is 2013-12.
What conditions does trial NCT01331005 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT01331005?
The interventions under investigation include: nepafenac 0.1% drops (DRUG), Nepafenac Vehicle (OTHER).
Who is sponsoring clinical trial NCT01331005?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01331005 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Hawaii, Indiana. 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.