A Phase 3 interventional study of AVT29 (proposed aflibercept HD biosimilar) and Eylea HD (aflibercept HD) in Diabetic Macular Edema, sponsored by Alvotech Swiss AG. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Alvotech Swiss AG · Phase 3, Interventional, and Treatment
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.
Alvotech Swiss AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
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.
Drug: AVT29 (proposed aflibercept HD biosimilar)
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.
Drug: Eylea HD (aflibercept HD)
Patients will receive IVT injections of AVT29
Patients will receive IVT injections of Eylea HD
Change from baseline to Week 8 in BCVA as measured by ETDRS letter score
Time frame: week 8
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Alvotech Swiss AG