Safety and Immunogenicity of PRO-169 in Patients With Diabetic Macular Edema

Starting soon · Phase 1

Conditions studied: Immunogenicity, Anti-drug Antibodies (ADAs)

In brief

Phase I, prospective, interventional, open-label, multicenter clinical trial to evaluate the safety of intravitreal PRO-169 through the presence of serum anti-drug antibodies (ADAs) to bevacizumab.

Key facts

Study ID

NCT07429474

Run by

Laboratorios Sophia S.A de C.V.

People needed

60

Starts

2026-03-01

Expected to finish

2026-12-15

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Diagnosis of type 1 or type 2 diabetes.
• Ability to provide signed informed consent.
• Ability and willingness to comply with scheduled visits, treatment plan, and other study procedures.
• All subjects (male and female) who are biologically capable of having children must agree and commit to using a barrier or hormonal contraceptive method (by any route of administration) for the entire duration of the study and for 3 months after the last intravitreal injection.
• Female subjects who are biologically capable of having children must have a negative urine pregnancy test at the screening visit.
• Best-corrected visual acuity (BCVA) according to the ETDRS chart from 24 to 78 letters (approximate Snellen equivalent of 20/32 to 20/320).
• Diabetic macular edema with central involvement evidenced by spectral domain optical coherence tomography (central macular thickness criterion > 300 µm for men and > 290 µm for women) within 8 days prior to inclusion. All measurements taken on a subject must be taken with an instrument of the same make and model throughout the study.
• Meet characteristics that allow for adequate fundus examination (media transparency, adequate pupil dilation).
• Glycosylated hemoglobin < 12% from a result no older than 3 months.

You may not qualify if…

• Chronic kidney disease with renal failure (glomerular filtration rate [eGFR] <15 mL/min/1.73 m2) requiring dialysis or transplantation; according to the 2020 Clinical Practice Guideline for the Management of Diabetes in Chronic Kidney Disease from the Kidney Disease Improving Global Outcomes (KDIGO) organization.
• Active proliferative diabetic retinopathy in the study eye, including rubeosis iridis, vitreous hemorrhage, or tractional retinal detachment visible during the screening visit.
• Individuals who have required initiation of insulin therapy for glycemic control within 4 months prior to the screening visit.
• Previous participation in clinical studies with investigational products, ocular or systemic (at least 30 days must have elapsed between the end of participation in a previous trial and inclusion in this study).
• Known hypersensitivity or allergy to bevacizumab or any ingredient in the investigational product.
• Poorly controlled blood pressure (average of 3 blood pressure readings in a seated position with ≥160 mmHg systolic or ≥100 mmHg diastolic) at the screening visit.
• Myocardial infarction or other cardiovascular event (cerebrovascular disease, transient cerebral ischemia, or hospitalization for heart failure) during the 4 months prior to the screening visit, or subjects with active myocardial ischemia.
• Systemic treatment with VEGF-related drugs within 4 months prior to the screening visit.
• History of any rheumatological or collagen disease of autoimmune origin related to inflammatory processes such as: systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, Behçet's disease, dermatomyositis, among others.
• History of any disease that causes immunosuppression or immunodepression, except diabetes mellitus.
• Concomitant use of immunosuppressive agents, immunotherapy, or monoclonal antibodies by any route of administration (other than intravitreal) in the 2 years prior to the screening visit or during the study period.
• Subjects who have received intravitreal anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, faricimab, brolucizumab) in the study eye within 4 months prior to the screening visit.
• Use of intraocular or periocular corticosteroids in the study eye within 4 months prior to the screening visit, or use of intravitreal corticosteroid implants at any time.
• Use of anticoagulants or antiplatelet agents by any route of administration within 10 days prior to the screening visit or during the study period.
• Women of childbearing potential who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• Allergy to fluorescein (topical or intravenous) or to anesthetic medications used during the injection procedure.
• Subjects with non-diabetic macular edema.
• Lens opacities that, according to the LOCS III (Lens Opacities Classification System) classification, exceed one or more of the following criteria: nuclear component > NO3C3 (opalescence/color), cortical component > C2, and posterior subcapsular component > P1.
• History of eye surgery (cataract extraction, any intraocular surgery, aphakia, etc.) or panretinal photocoagulation within 3 months prior to the screening visit or planned within the study period.
• Intraocular pressure greater than 21 mmHg in the selected eye, measured by Goldmann tonometry at the screening visit.
• Presence of macular ischemia or significant perifoveal capillary loss (increase in foveal avascular zone greater than 350 µm) demonstrated by fluorescein retinal angiography (during the screening visit or in a study performed within 4 months prior to the screening visit).
• History of YAG capsulotomy in the study eye within 30 days prior to the screening visit.
• Evidence of external eye infections, intraocular inflammation, or significant ocular surface disease in either eye within 30 days prior to the screening visit.
• History of uveitis in the study eye.
• History of retinal detachment, vitrectomy, any type of filtering surgery, corneal transplant, or corneal dystrophy in the selected eye.

Where it is running

• Asociación para Evitar la Ceguera en México I.A.P — Coyoacán, Mexico City, Mexico

Full record on ClinicalTrials.gov

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