Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AVT29 (proposed aflibercept HD biosimilar), Eylea HD (aflibercept HD).
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema
Overview
This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.
Interventions
- Drug AVT29 (proposed aflibercept HD biosimilar)
Patients will receive IVT injections of AVT29 - Drug Eylea HD (aflibercept HD)
Patients will receive IVT injections of Eylea HD
Primary outcome measures
- Change from baseline to Week 8 in BCVA as measured by ETDRS letter score [Time frame: week 8]
Eligibility criteria
Main Inclusion Criteria:
- Participant is ≥18 years old at the time of signing the ICF.
- Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.
- Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.
- Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20/40 to 20/200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.
- Participant's decrease in vision is determined to be primarily the result of DME in the study eye.
Main Exclusion Criteria:
- previous treatment with anti-VEGF therapy
- history or concurrent disease other than DME that could compromise visual acuity
- 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
- participants 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- Site 3004 — Budapest
Identifiers
NCT: NCT07489131 · AVT29-GL-C01