drugset / Trial / NCT05217680

Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

NCT05217680

Phase 3 Completed 509 enrolled Laboratorios Sophia S.A de C.V.
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

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 1.25 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal