A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT04527107
- Run by
- Oxurion
- People needed
- 135
- Starts
- 2020-07-31
- Expected to finish
- 2023-11-22
- Last updated by the study team
- 2023-11-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Retina Associates — Tucson, Arizona, United States
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
- Salehi Retina Institute Inc. — Huntington Beach, California, United States
- Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States
- California Retina Consultants — Oxnard, California, United States
- Retina Consultants San Diego — Poway, California, United States
- Retinal Consultants Medical Group — Sacramento, California, United States
- Retina Consultants of Southern Colorado, P.C. — Colorado Springs, Colorado, United States
- Blue Ocean Clinical Research — Clearwater, Florida, United States
- Fort Lauderdale Eye Institute — Plantation, Florida, United States
- MedEye Associates — South Miami, Florida, United States
- Center for Retina and Macular Disease — Winter Haven, Florida, United States
- Southeast Retina Center — Augusta, Georgia, United States
- Marietta Eye Clinic — Marietta, Georgia, United States
- University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
- Joslin Diabetes Center — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Sierra Eye Associates — Reno, Nevada, United States
- Retina-Vitreous Surgeons of Central New York, PC — Liverpool, New York, United States
- Cincinnati Eye Institute — Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Retina Associates of Cleveland, Inc — Cleveland, Ohio, United States
- Sterling Vision, P.C. dba Oregon Retina — Eugene, Oregon, United States
- Retinal Research Institute, LLC — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.