drugset / Trial / NCT05217680
Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase III clinical study to evaluate the efficacy, expressed as improvement in visual acuity in patients suffering diabetic macular edema after one year of treatment with PRO-169, compared to treatment with Lucentis® (ranibizumab).
Timeline
- Start
- 2021-05-24
- Primary completion
- 2025-08-18
- Completion
- 2025-11-25
Publications
- Salcedo-Villanueva G, Garcia-Sanchez G, Palacio-Pastrana C, Gascon-Guzman G, Moreno-Andrade A, Olvera-Montano O, Munoz-Villegas P. One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population. Int J Retina Vitreous. 2025 Aug 1;11(1):89. doi: 10.1186/s40942-025-00719-9.
- Torres-Arellano JM, Tornero-Jimenez A, Sanchez-Rios A, Olvera-Montano O, Munoz-Villegas P. Evaluation of the Relationship Between Diabetic Macular Edema and Renal Function in a Latino Population. Ophthalmol Ther. 2023 Oct;12(5):2745-2755. doi: 10.1007/s40123-023-00787-w. Epub 2023 Aug 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 1.25 mg | Intravitreal |
| Comparator | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |