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Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

NCT05217680 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2026-03-16

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Bevacizumab

Administration of monthly intravitreal bevacizumab (4-12 injections)

BIOLOGICAL

Lucentis®

Administration of monthly intravitreal ranibizumab (4-12 injections)

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2025-08-18
Completion
2025-11-25

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217680 on ClinicalTrials.gov