Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

Sponsor
Laboratorios Sophia S.A de C.V.
Study ID
NCT05217680
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Administration of monthly intravitreal bevacizumab (4-12 injections)
  • Lucentis® — BIOLOGICAL
    Administration of monthly intravitreal ranibizumab (4-12 injections)

Study Details

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).

Key Dates

First listed
Feb 1, 2022
Start date
May 24, 2021
Status verified
May 2026
Primary completion
Aug 18, 2025
Completion
Nov 25, 2025

Study Design

Enrollment
509 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRO-169
    Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
  • Active Comparator: Lucentis ®
    Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.

Primary Outcome Measure

Best Corrected Visual Acuity [ Time Frame: Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) ]

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