Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

NCT05217680 | Completed Phase 3

• 1 other identifier: SOPH169-0718/III
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

  Days: 0 (selection), 1 (randomization), 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)

Secondary Outcomes (8)

• Best Corrected Visual Acuity area under the curve

  Days: 0 (selection), 1 (randomization), 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)

• Best Corrected Visual Acuity (adjusted to baseline)

  Days: 0 (selection), 1 (randomization), 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5)

• Central Macular Thickness

  Days: 0 (selection), 1 (randomization), 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)

• Retinal Volume

  Days: 0 (selection), 1 (randomization), 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)

• Percentage of patients with a positive response to treatment.

  Days: 0 (selection), 1 (randomization), 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit)

Study Arms (2)

PRO-169

EXPERIMENTAL

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.

Biological: Bevacizumab

Lucentis ®

ACTIVE COMPARATOR

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.

Biological: Lucentis®

Interventions

Bevacizumab BIOLOGICAL

Administration of monthly intravitreal bevacizumab (4-12 injections)

PRO-169

Lucentis® BIOLOGICAL

Administration of monthly intravitreal ranibizumab (4-12 injections)

Lucentis ®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of Diabetes Mellitus (type 1 or 2) evidenced by: use of insulin or use of oral hypoglycemic medications or diagnosis for DM according to OMS or ADA criteria.
• Is capable of rendering informed consent.
• HbA1c \<8.5% in selection visit.
• All men and women capable of reproduction may agree to use a barrier birth control method during the study and 3 months after the last intravitreal injection applied.
• Only one eye may be randomized per participating individual, in case both are eligible, the investigator may choose either eye according his/her criteria.
• BVCA according to ETDRS between \<78 (20/32 or worse) and \>24 (20/320 or better) within 8 days prior to the randomization.
• Clinically evident diabetic macular edema, with central macular thickening.
• Diabetic macular edema demonstrated in OCT scan (macular central thickness \> 300 μm for men and \> 290 μm for women) within 8 days prior to the randomization.
• Presenting characteristics that allow an adequate fundus examination (transparent means, adequate pupil dilation, etc).

You may not qualify if:

• Chronic renal disease with renal insufficiency that requires dialysis or transplant.
• Individuals with conditions that may compromise their participation during the span of the study (unstable concomitant diseases, possible change of residence, etc)
• Individuals with a poor glycemic control who have started insulin treatment within 4 months previous to the study.
• Participation in another clinical study (at least 90 days must have elapsed between the finalization of his/her participation in a previous essay and randomization in the present study).
• Known allergies to the treatment.
• Poorly controlled blood pressure (average of 3 readings while sitting with ≥160 mmHg systolic or ≥100 mmHg diastolic in the selection visit.
• Heart attack or other cardiovascular event (cerebral vascular disease, transitory ischemia, hospitalization for cardiac insufficiency) during the 4 months prior to the start of the study, or patients with active myocardial insufficiency.
• Previous systemic treatment with VEGF-related medications within 4 months prior to the start of the study.
• Women of child-bearing age who are pregnant, lactating of planning to get pregnant within the time span of the study.
• Known allergy to anesthetic medications used during the procedures, intravitreal injection and photocoagulation.
• Diagnosis of non-diabetic macular edema.
• Ophthalmic conditions that interfere with the evaluation of BCVA (for example: foveal atrophy, pigmentary abnormalities, dense foveal exudates, etc)
• Additional conditions to DM that may compromise the evaluation of the edema (for example: venous occlusions, uveitis or other inflammatory diseases, neovascular glaucoma, etc)
• Lens opacities that according to the LOCS III classification system exceed one or more of the following: \> NO3C3, \> C2, \> P1.
• Previous history of anti-VEGF treatment for diabetic macular edema or any treatment for diabetic macular edema within 4 months prior to the start of the study (corticosteroids, photocoagulation, etc)

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

SalaUno Salud, S.A.P.I. de C.V.

Mexico City, 06030, Mexico

Location

Related Publications (2)

• Salcedo-Villanueva G, Garcia-Sanchez G, Palacio-Pastrana C, Gascon-Guzman G, Moreno-Andrade A, Olvera-Montano O, Munoz-Villegas P. One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population. Int J Retina Vitreous. 2025 Aug 1;11(1):89. doi: 10.1186/s40942-025-00719-9.

  PMID: 40750915 DERIVED

• Torres-Arellano JM, Tornero-Jimenez A, Sanchez-Rios A, Olvera-Montano O, Munoz-Villegas P. Evaluation of the Relationship Between Diabetic Macular Edema and Renal Function in a Latino Population. Ophthalmol Ther. 2023 Oct;12(5):2745-2755. doi: 10.1007/s40123-023-00787-w. Epub 2023 Aug 6.

  PMID: 37543959 DERIVED

MeSH Terms

Interventions

Bevacizumab; Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical study, phase III, multi-centric, randomized, double-blind, with active parallel control to show non-inferiority.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: May 24, 2021
• Primary Completion: August 18, 2025
• Study Completion: November 25, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)