Evaluating PRO-169 for treating Diabetic Macular Edema

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

This study is testing if a new treatment called PRO-169 can help people with diabetic macular edema see better compared to an existing treatment called Lucentis.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 442 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laboratorios Sophia S.A de C.V. (industry)
• Drugs / interventions: ranibizumab, bevacizumab
• Locations: 2 sites (Bogotá and 1 other locations)
• Trial ID: NCT05217680 on ClinicalTrials.gov

What this trial studies

This Phase III clinical study aims to assess the efficacy of PRO-169 (bevacizumab) in improving visual acuity in patients with diabetic macular edema, compared to Lucentis® (ranibizumab). A total of 442 patients will be randomized to receive either treatment, with monthly evaluations including ophthalmologic assessments and OCT imaging. The study will involve 14 visits, with treatment adjustments based on patient response and predetermined algorithms. Rescue therapy may be applied if necessary, based on specific criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of diabetes and clinically evident diabetic macular edema.

Not a fit: Patients with HbA1c levels above 8.5% or those not meeting the specific visual acuity and OCT criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision for patients suffering from diabetic macular edema.

How similar studies have performed: Previous studies have shown promising results with similar treatments for diabetic macular edema, indicating potential for success in this approach.

Eligibility criteria

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.
* 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)
* 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.

Where this trial is running

Bogotá and 1 other locations

• Fundación Oftalmológica Nacional — Bogotá, Colombia (NOT_YET_RECRUITING)
• SalaUno Salud, S.A.P.I. de C.V. — Ciudad de Mexico, Mexico (RECRUITING)

Study contacts

• Study coordinator: Alejandra Sanchez-Rios, MD

Conditions: Diabetic Macular Edema