Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.

Official Title
-----------------
A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)

Conditions
-----------------
Neovascular (Wet) AMD

Intervention / Treatment
-----------------
* Drug: AVT06 (proposed aflibercept biosimilar)
* Drug: Eylea® (Aflibercept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be ≥50 years of age, at the time of signing the informed consent. Subjects must be diagnosed with neovascular (wet) AMD in the study eye. Subjects must have active, treatment naïve, subfoveal CNV lesions secondary to neovascular (wet) AMD. Willingness and ability to undertake all scheduled visits and assessments. Exclusion Criteria: Any prior systemic treatment with anti-VEGF therapy Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data Prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment Subjects not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVT06 (proposed aflibercept biosimilar)<br>Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. | Drug: AVT06 (proposed aflibercept biosimilar)<br>* Patients will receive IVT injections of AVT06<br>|
| Experimental: Eylea® (Aflibercept)<br>Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. | Drug: Eylea® (Aflibercept)<br>* Patients will receive IVT injections of Eylea®<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) |  | Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aflibercept, Macular Degeneration, Retinal Degeneration