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COMPLETED Phase 3

PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

NCT02374060 · View on ClinicalTrials.gov ↗

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

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02374060

The ClinicalTrials.gov registry entry for NCT02374060 describes a study currently listed as completed. It is categorized as Phase 3, 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 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JHSPH Center for Clinical Trials, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT02374060 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Pennsylvania, California, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02374060?

This trial is sponsored by JHSPH Center for Clinical Trials, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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