NCT05217680

Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A total of 442 patients with diabetic macular edema will be randomized 1:1 to be treated with either PRO-169 (bevacizumab) or Lucentis® (ranibizumab). There will be a total of 14 visits, including selection and final visits. Monthly evaluations will include ophthalmologic evaluations of anterior and posterior segments, as well as OCT (optic coherence tomography) to obtain central macular width and retinal volume. Fluorescein angiography will be performed on selection visit as well as 6 and 12 months into the study (visits 7 and 13). All patients will be exposed to intravitreal injection of either of the studied drugs monthly for the first 4 months. Starting on visit 5 patients will be injected depending on their response to treatment, calculated according predetermined algorithms including clinical and image variables. Starting on month 6, patients may be subjected to rescue therapy with photocoagulation if they comply with predetermined criteria for such measure.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Administration of monthly intravitreal bevacizumab (4-12 injections)
BIOLOGICAL	Lucentis®	Administration of monthly intravitreal ranibizumab (4-12 injections)

Timeline

• Start date: 2021-05-24
• Primary completion: 2025-08-18
• Completion: 2025-11-25
• First posted: 2022-02-01
• Last updated: 2026-03-16

Locations

1 site across 1 country: Mexico