Safety and Immunogenicity of PRO-169 in Patients With Diabetic Macular Edema
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratorios Sophia S.A de C.V.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- PRO-169
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov