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Diabetic Macular EdemaPhase 3PRO-169NCT05217680

Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

A Phase 3 study testing Bevacizumab and Lucentis® in people with Diabetic Macular Edema, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Bevacizumab and Lucentis®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
509 participants
Where
1 siteMexico
Study dates
24 May 2021to 25 Nov 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 <9.5% 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.
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  • 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).

Who cannot join

  • 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.
Show all 23Show fewer
  • 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)
  • Anticipation of the need of panphotocoagulation (for example: proliferative diabetic retinopathy or any other indication) during the period of the study or history of panphotocoagulation within the 4 months prior to the start of the study.
  • History of ocular surgery (cataract extraction, any intraocular surgery, aphakia, etc) within 4 months prior to the start of the study, or planned to occur within the time span of the study.
  • Intraocular pressure > 21 mmHg, measured through Goldmann tonometry during the selection visit.
  • Presence of macular ischemia or important loss of perifoveal capilaries (avascular foveal zone greater than 350 μm) demonstrated through fluorescein angiography during the selection visit.
  • Evidence of macular traction and hyaloid thickening in OCT scan.
  • History of YAG capsulotomy within 2 months prior to the randomization.
  • Evidence of external ocular infections or any important disease of the ocular surface.
  • History of vitrectomy.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • SalaUno Salud, S.A.P.I. de C.V.

    Mexico City, 06030

Other trials in Mexico

About this study

Official title: Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema

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).

Read the detailed description

A total of 442 patients with diabetic macular edema will be randomized 1:1 to be treated with either PRO-169 (bevacizumab) or Lucentis® (ranibizumab). There will be a total of 14 visits, including selection and final visits. Monthly evaluations will include ophthalmologic evaluations of anterior and posterior segments, as well as OCT (optic coherence tomography) to obtain central macular width and retinal volume. Fluorescein angiography will be performed on selection visit as well as 6 and 12 months into the study (visits 7 and 13). All patients will be exposed to intravitreal injection of either of the studied drugs monthly for the first 4 months. Starting on visit 5 patients will be injected depending on their response to treatment, calculated according predetermined algorithms including clinical and image variables. Starting on month 6, patients may be subjected to rescue therapy with photocoagulation if they comply with predetermined criteria for such measure.

Being tested
Bevacizumab, Lucentis®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Administration of monthly intravitreal bevacizumab (4-12 injections)

  • Lucentis®Biological

    Administration of monthly intravitreal ranibizumab (4-12 injections)

Study groups in NCT05217680
Study groupRoleWhat they receive
PRO-169ExperimentalBevacizumab 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.
Receives: Biological: Bevacizumab
Lucentis ®Active comparatorRanibizumab 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.
Receives: Biological: Lucentis®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

Secondary outcomes (10)

  1. Best Corrected Visual Acuity Area Under the Curve

    Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The area under the curve of both treatments will be used evaluated as difference between baseline and final (12 months) values.

    Measured: 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)

  2. Best Corrected Visual Acuity

    Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The corrected BCVA (adjusted to baseline value) of both treatments will be used evaluated at 4 months. The value was obtained from the value obtained on day 120 minus the baseline value.

    Measured: Day 120±3 (Visit 5)

  3. Central Macular Thickness

    Central macular thickness will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

    Measured: 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)

  4. Retinal Volume

    Retinal volume will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values.

    Measured: Day 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)

  5. Percentage of Patients With a Positive Response to Treatment.

    Determining the percentage of patients with a positive response to treatment, considered as: absolute improvement (20/20 vision for two consecutive visits and central macular thickness < 300 μm in men and < 290 μm in women), improvement (one or more of the following: patient who gained 5 or more letters for BCVA, ≥ 10% decrease of macular central thickness value compared to last two visits) and stability (one or more of the following: patient with neither a gain of 5 or more letters for BCVA nor a ≥ 10% decrease of macular central thickness value compared to last two visits, patient without loss of 5 or more letters for BCVA or a ≥ 10% decrease of macular central thickness value compared to last visit).

    Measured: 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)

  6. Mean Number of Injections

    Determining the mean number of injections applied during study, comparing both arms.

    Measured: 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)

  7. Frequency of Rescue Therapy Administration

    Number of patients who required photocoagulation treatment

    Measured: 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)

  8. Adverse Events Related to the Injection

    This section describes the treatment-related adverse events reported throughout the study

    Measured: Day 360±3 (Final Visit)

  9. Ophthalmic Drug-related Adverse Events

    The number of adverse events related to the eyes associated with the medication is described.

    Measured: Day 360±3 (Final Visit)

  10. Systemic Drug-related Adverse Events

    The number of treatment-related adverse events at the systemic level is described

    Measured: Day 360±3 (Final Visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start24 May 2021
  3. Primary completion18 Aug 2025
  4. Study completion25 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Clinical study, phase III, multi-centric, randomized, double-blind, with active parallel control to show non-inferiority.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05217680
Sponsor's protocol ID
SOPH169-0718/III
Acronym
PRO-169
Status last verified
Sep 2026
First submitted
19 Jan 2022
Last updated
14 Oct 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40750915

  • 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.

    PubMed 37543959

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab and Lucentis® in people with Diabetic Macular Edema, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05217680, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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