CompletedPhase 3

Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

Mexico509 participantsStarted 2021-05-24

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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. * Parti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best Corrected Visual Acuity

Timeframe: 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)

Trial details

NCT IDNCT05217680

SponsorLaboratorios Sophia S.A de C.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-18

Results submitted2026-03-26

View on ClinicalTrials.gov More Diabetic Macular Edema trials