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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PRO-169
Biological/VaccineBevacizumab 1.25 mg / 0.05mL for intravitreal injection.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: PRO-169Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Day 0 (Selection), day 30± 5 (visit 5, V5), day 60 ± 5 (visit 6, V6) and day 90± 5 (final visit, FV)Secondary outcomes
1
Incidence of adverse events related to the IP.
An adverse event is considered to be any adverse medical occurrence that happens to a patient or clinical research subject who has been administered a pharmaceutical product and where a causal relationship is at least reasonably possible.
Time frame
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)2
Incidence of serious adverse events related to the IP.
A serious adverse event is considered to be any event that results in: death, life-threatening, requires hospitalization or prolongs hospitalization, causes permanent or significant disability or incapacity, causes alterations or malformations in the newborn, or other medically important conditions.
Time frame
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)3
Total area under the curve (AUC) of PRO-169 serum concentration
The total amount of drug that reaches the systemic circulation. It is an important measure of bioavailability and relates variations in the serum concentration of a drug over time.
Time frame
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)4
Maximum serum concentration (Cmax) of PRO-169
Maximum serum concentration of the drug
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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