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NCT02374060 · ClinicalTrials.gov registry record · Phase 3

PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

A Phase 3 study of Uveitis and Macular Edema, sponsored by JHSPH Center for Clinical Trials.

Completed
Registry status
Phase 3
Development phase
192
Enrollment target
20
Study locations

NCT02374060 is a Phase 3 study of Uveitis and Macular Edema that has completed, run by JHSPH Center for Clinical Trials. The registered enrollment target is 192 participants, below the 607-participant average among 19 other Uveitis trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT02374060, a Phase 3 study of Uveitis and Macular Edema, has completed, sponsored by JHSPH Center for Clinical Trials.

COMPLETED
Registry status
Phase 3
Development phase
192 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects. Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192 subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned interim analysis and recommended that the goals of the trial could be accomplished by completing follow-up of enrolled subjects without the recruitment of additional subjects. Per the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was completed according to the protocol.

Conditions Studied

Interventions

  • DRUG Dexamethasone intravitreal implant
  • DRUG Periocular triamcinolone 40 mg
  • DRUG Intravitreal triamcinolone 4 mg

Study Locations (20)

Pennsylvania

  • Scheie Eye Institute, University of Pennsylvania - Philadelphia
  • Wills Eye Hospital - Philadelphia
  • Unniversity of Pittsburgh Medical Center - Pittsburgh

California

  • Jules Stein Eye Institute, UCLA - Los Angeles
  • University of California, San Francisco - San Francisco

Florida

  • Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine - Miami
  • University of South Florida - Tampa

Illinois

  • Northwestern University - Chicago
  • Rush University Medical Center - Chicago

Maryland

  • Johns Hopkins University - Baltimore
  • National Eye Institute, NIH - Bethesda

Massachusetts

  • Massachusetts Eye and Ear Infirmary - Boston
  • Ophthalmic Consultants of Boston - Boston

Georgia

  • Emory University - Atlanta

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 192 participants
Start Date 2015-06-16
Est. Completion 2018-01-04
Phase Phase 3

Sponsor

JHSPH Center for Clinical Trials

12 total trials

What the Registry Record Tells You About NCT02374060

The ClinicalTrials.gov registry entry for NCT02374060 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 607-participant average among 19 other Uveitis trials with a reported enrollment target (68% lower). The listed sponsor is JHSPH Center for Clinical Trials, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Uveitis appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone intravitreal implant is the first listed.

NCT02374060 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Pennsylvania, California, Florida.

Frequently Asked Questions

What is clinical trial NCT02374060 about?

NCT02374060 is a clinical study titled "PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial". To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change...

What is the current status of trial NCT02374060?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 192 participants. The study started on 2015-06-16. Estimated completion is 2018-01-04.

What conditions does trial NCT02374060 study?

This clinical trial studies the following conditions: Uveitis, Macular Edema.

What interventions are being tested in trial NCT02374060?

The interventions under investigation include: Dexamethasone intravitreal implant (DRUG), Periocular triamcinolone 40 mg (DRUG), Intravitreal triamcinolone 4 mg (DRUG).

Who is sponsoring clinical trial NCT02374060?

This trial is sponsored by JHSPH Center for Clinical Trials, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02374060 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.