Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
NCT04527107 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04527107
The ClinicalTrials.gov registry entry for NCT04527107 describes a study currently listed as completed. It is categorized as Phase 2, 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 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oxurion, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT04527107 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04527107?
This trial is sponsored by Oxurion, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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