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

NCT07429474 | Not Yet Recruiting Phase 1

• 1 other identifier: PRO-169-1224-I
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunogenicity; Anti-drug Antibodies (ADAs)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with positive serum ADAs for bevacizumab.

  Positive results will be those where the baseline result shows no presence of ADAs (i.e., the result obtained in the blood sample for immunogenicity collected during the screening visit) and at least one sample shows the presence of ADAs after starting treatment with PRO-169. Baseline result with the presence of ADAs and at least one sample with a result ≥ 4 times the baseline titers after initiation of treatment with PRO-169.

  Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

Secondary Outcomes (7)

• Incidence of adverse events related to the IP.

  Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

• Incidence of serious adverse events related to the IP.

  Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

• Total area under the curve (AUC) of PRO-169 serum concentration

  Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

• Maximum serum concentration (Cmax) of PRO-169

  Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

• Maximum serum time (Tmax) of PRO-169

  Day 0 (Selection, SV), day 1(Visit 1, V1), day 2 (Visit 2, V2), day 4 (Visit 3, V3), day 8 (Visit 4, V4), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)

Study Arms (1)

PRO-169

EXPERIMENTAL

Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All participants included in the study will receive an injection of the investigational product every 30 days for two months (a total of 3 doses will be administered).

Biological: PRO-169

Interventions

PRO-169 BIOLOGICAL

Bevacizumab 1.25 mg / 0.05mL for intravitreal injection.

PRO-169

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 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).
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Asociación para Evitar la Ceguera en México I.A.P

Coyoacán, Mexico City, 04030, Mexico

Location

Central Study Contacts

Alejandra Sanchez-Rios, MD

CONTACT

+52 33 3001 4200; alejandra.sanchez@sophia.com.mx

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I clinical trial, prospective, interventional, open-label, multicenter. In addition to the general safety variables of the study, pharmacokinetics will be evaluated in a cohort of 15 subjects.

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)