CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 509 enrolled
Drug / intervention
Bevacizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05217680
NCT05217680Phase 3Completed
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Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema

Laboratorios Sophia S.A de C.V.·interventional·Posted Feb 1, 2022·Updated May 26, 2026

In Brief

A Phase 3 clinical trial evaluating Bevacizumab and Lucentis® for Diabetic Macular Edema. Completed, enrolled 509 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesMexico
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedFeb 1, 2022
Enrollment StartMay 24, 2021
Primary CompletionAug 18, 2025
Study CompletionNov 25, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 4.4 years ago

Interventions

Bevacizumabbiological

Administration of monthly intravitreal bevacizumab (4-12 injections)

Lucentis®biological

Administration of monthly intravitreal ranibizumab (4-12 injections)