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NCT04527107 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
A Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema, sponsored by Oxurion.
- Completed
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT04527107: Completed Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema, sponsored by Oxurion.
NCT04527107 is a Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema that has completed, run by Oxurion. The registered enrollment target is 135 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04527107, a Phase 2 study of Diabetes Mellitus and Diabetic Macular Edema, has completed, sponsored by Oxurion.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
Conditions Studied
Interventions
- DRUG THR-149 dose level 1
- DRUG THR-149 dose level 2
- DRUG THR-149 dose level 3
- DRUG THR-149 0.13mg
- DRUG THR-149 0.13mg + aflibercept 2mg
Study Locations (20)
California
- Retina-Vitreous Associates Medical Group - Beverly Hills
- Salehi Retina Institute Inc. - Huntington Beach
- Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View
- California Retina Consultants - Oxnard
- Retina Consultants San Diego - Poway
- Retinal Consultants Medical Group - Sacramento
Florida
- Blue Ocean Clinical Research - Clearwater
- Fort Lauderdale Eye Institute - Plantation
- MedEye Associates - South Miami
- Center for Retina and Macular Disease - Winter Haven
Arizona
- Retinal Research Institute, LLC - Phoenix
- Retina Associates - Tucson
Georgia
- Southeast Retina Center - Augusta
- Marietta Eye Clinic - Marietta
Colorado
- Retina Consultants of Southern Colorado, P.C. - Colorado Springs
Illinois
- University Retina and Macula Associates, PC - Oak Forest
Maryland
- Cumberland Valley Retina Consultants - Hagerstown
Massachusetts
- Joslin Diabetes Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2023-11-22 |
| Phase | Phase 2 |
What the finished NCT04527107 record still lists
NCT04527107 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 5 interventions - of which THR-149 dose level 1 is the first listed.
NCT04527107 names 20 study sites across 10 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04527107 about?
NCT04527107 is a clinical study titled "A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema". Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibe...
What is the current status of trial NCT04527107?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2020-07-31. Estimated completion is 2023-11-22.
What conditions does trial NCT04527107 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Diabetic Macular Edema, Diabetic Retinopathy.
What interventions are being tested in trial NCT04527107?
The interventions under investigation include: THR-149 dose level 1 (DRUG), THR-149 dose level 2 (DRUG), THR-149 dose level 3 (DRUG), THR-149 0.13mg (DRUG), THR-149 0.13mg + aflibercept 2mg (DRUG).
Who is sponsoring clinical trial NCT04527107?
This trial is sponsored by Oxurion, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04527107 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04527107's enrollment target sits among peer trials
135 106th of 208 higher than 103 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus 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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