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COMPLETED Phase 2

NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)

NCT01331005 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 125 participants
Start Date 2011-05
Est. Completion 2013-12
Phase Phase 2

Sponsor

Jaeb Center for Health Research

134 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01331005 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01331005?

The interventions under investigation include: nepafenac 0.1% drops (DRUG), Nepafenac Vehicle (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01331005?

This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial