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NCT02623426 · ClinicalTrials.gov registry record · Phase 3
Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial
A Phase 3 study of Uveitis and Macular Edema, sponsored by JHSPH Center for Clinical Trials.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT02623426: Completed Phase 3 study of Uveitis and Macular Edema, sponsored by JHSPH Center for Clinical Trials.
NCT02623426 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 194 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 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02623426, 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
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a parallel design (1:1:1), randomized comparative trial with an anniversary close-out after 6 months of follow-up. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.
Primary Outcome
The primary outcome is the change in central subfield thickness from baseline to 12 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. The proportion of baseline subfield thickness is estimated by a mixed effect model that includes time points for baseline, week 4, week 8, and week 12 and the treatment group. The treatment effect is the interaction (product) of time point and treatment. Contrasts of the model parameter estimates were used to calc
Conditions Studied
Interventions
- DRUG Dexamethasone intravitreal implant 0.7 mg
- DRUG Intravitreal Methotrexate 400 µg
- DRUG Intravitreal Ranibizumab 0.5 mg
Study Locations (20)
Pennsylvania
- Scheie Eye Institute, University of Pennsylvania - Philadelphia
- MidAtlanitc Retina, Wills Eye Hospital - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
California
- Jules Stein Eye Institute, UCLA - Los Angeles
- University of California, San Francisco - San Francisco
Illinois
- Northwestern University - Chicago
- Rush University Medical Center - Chicago
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
- Ophthalmic Consultants of Boston - Boston
Florida
- Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine - Miami
Georgia
- Emory University - Atlanta
Iowa
- University of Iowa - Iowa City
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2017-03-09 |
| Est. Completion | 2022-02-02 |
| Phase | Phase 3 |
What the finished NCT02623426 record still lists
NCT02623426 is an interventional study that assigns participants to a tested intervention. The registered 194 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 0.7 mg is the first listed.
NCT02623426 names 20 study sites across 15 states, led by Pennsylvania, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT02623426 about?
NCT02623426 is a clinical study titled "Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial". The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, intravitreal ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular edema persisting or reoccurring ...
What is the current status of trial NCT02623426?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2017-03-09. Estimated completion is 2022-02-02.
What conditions does trial NCT02623426 study?
This clinical trial studies the following conditions: Uveitis, Macular Edema.
What interventions are being tested in trial NCT02623426?
The interventions under investigation include: Dexamethasone intravitreal implant 0.7 mg (DRUG), Intravitreal Methotrexate 400 µg (DRUG), Intravitreal Ranibizumab 0.5 mg (DRUG).
Who is sponsoring clinical trial NCT02623426?
This trial is sponsored by JHSPH Center for Clinical Trials, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02623426 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
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Where NCT02623426's enrollment target sits among peer trials
194 7th of 19 higher than 13 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.
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