Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema

Sponsor
Alvotech Swiss AG
Study ID
NCT07489131
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 22, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
256 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AVT29 (proposed aflibercept HD biosimilar)
    Participants will receive 1 IVT injection of AVT29 at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.
  • Active Comparator: Eylea HD (aflibercept HD)
    Participants will receive 1 IVT injection of Eylea HD at baseline and every 4 weeks for 2 consecutive monthly visits (at Week 4 and Week 8), followed by 1 IVT injection every 8 to 16 weeks based on DRM criteria through study completion.

Primary Outcome Measure

Change from baseline to Week 8 in BCVA as measured by ETDRS letter score [ Time Frame: week 8 ]

Central Contacts

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