Comparing AVT29 and Eylea HD for diabetic macular edema
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
This study will test whether AVT29 works as well and is as safe as Eylea HD in adults with center-involving diabetic macular edema who have reduced vision.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alvotech Swiss AG Industry-sponsored |
| Locations | 1 site (Budapest) |
| Trial ID | NCT07489131 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized, double-masked, parallel-group multicenter study compares the efficacy and safety of AVT29 (a proposed aflibercept HD biosimilar) with Eylea HD in adults with center-involving diabetic macular edema. Eligible participants are adults with vision between 73 and 34 ETDRS letters in the study eye and who have not previously received anti-VEGF therapy. Participants are randomized to receive one of the two injections and followed with standardized visual acuity and safety assessments over the study period. The trial's primary focus is on visual acuity outcomes and adverse events to determine whether AVT29 provides comparable benefit and tolerability to Eylea HD.
Who should consider this trial
Good fit: Adults (≥18 years) with center-involving diabetic macular edema, BCVA between 73 and 34 ETDRS letters (≈20/40 to 20/200), whose vision loss is primarily due to DME and who have not had prior anti-VEGF treatment are ideal candidates.
Not a fit: Patients who previously received anti-VEGF therapy, have other ocular diseases that limit vision, or cannot attend required visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, AVT29 could offer an effective alternative to Eylea HD, potentially increasing treatment options and access for patients with DME.
How similar studies have performed: Eylea (aflibercept) is an established effective treatment for DME, and biosimilar development programs for anti-VEGF drugs have shown comparable results for some agents, but aflibercept biosimilars are still being validated in Phase 3 trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Budapest
- Site 3004 — Budapest, Hungary (Recruiting)
Study contacts
- Study coordinator: Silvia Cirillo
- Email: alvotech.clinical@alvotech.com
- Phone: +41 78 659 89 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.