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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: Completed Phase 3 study of Uveitis and Macular Edema, sponsored by JHSPH Center for Clinical Trials.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickne
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
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2015-06-16 |
| Est. Completion | 2018-01-04 |
| Phase | Phase 3 |
What the finished NCT02374060 record still lists
NCT02374060 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 607-participant average among 19 other Uveitis trials with a reported enrollment target (68% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Uveitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02374060's enrollment target sits among peer trials
192 8th of 19 higher than 12 of 19 other Uveitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uveitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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