A Randomized, Double-masked Study Comparing the Efficacy and Safety of AVT29 Versus High-Dose Aflibercept in Participants with Diabetic Macular Edema

The primary objective of this study is to demonstrate the equivalent efficacy of AVT29 compared to a high dose of aflibercept in participants with diabetic macular edema. The secondary objectives include:

• Further assessment of efficacy;
• Evaluation of safety and tolerability;
• Assessment of immunogenicity;
• Evaluation of systemic pharmacokinetics in a subset of participants.

This clinical trial involves 84 participants diagnosed with diabetic macular edema. The study population includes both male and female patients aged between 18 and 64 years. Eligible individuals must have a diagnosis of type 1 or type 2 diabetes mellitus with a glycated hemoglobin level below 12% at the time of screening. Participation requires the provision of informed consent prior to any study-specific procedures.

This phase 3, randomized, double-masked, parallel-group, multicenter clinical study is designed to evaluate the efficacy and safety of aflibercept compared to a high dose of Eylea in participants with diabetic macular edema. The methodology aims to demonstrate the equivalent efficacy of the test product against the comparator. The primary endpoint is the change from baseline in best-corrected visual acuity as measured by the ETDRS letter score. Secondary endpoints include assessments of central subfield thickness via spectral domain optical coherence tomography, the absence of intraretinal fluid, intraocular pressure, and the incidence of treatment-emergent adverse events. The trial includes a screening visit to confirm eligibility, such as a diagnosis of diabetes mellitus with HbA1c levels below 12%. Following screening, participants undergo study visits to monitor ophthalmic parameters, pharmacokinetics, and the presence of anti-drug antibodies. The study is estimated to conclude by December 31, 2027.

The experimental treatment consists of aflibercept, administered as a solution for injection. The medication is delivered via intravitreal injection at a dosage of 8 mg.

The comparator treatment is Eylea, which is a 114.3 mg/ml solution for injection. This substance is also administered through intravitreal use at a dosage of 8 mg for participants with diabetic macular edema.

The efficacy of AVT29 in participants with diabetic macular edema is evaluated through several parameters. The primary endpoint is the change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Secondary efficacy assessments include the change from baseline in BCVA at several pre-defined time points, specifically monitoring the gain or loss of ≥5, ≥10, and ≥15 letters in the ETDRS score. Additionally, changes from baseline in central subfield thickness (CST) are assessed using spectral domain optical coherence tomography (SD-OCT). The absence of intraretinal fluid (IRF) is also measured via SD-OCT at pre-defined time points throughout the study.