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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar) | Experimental | 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. |
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| Eylea HD (aflibercept HD) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVT29 (proposed aflibercept HD biosimilar) | Drug | Patients will receive IVT injections of AVT29 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 8 in BCVA as measured by ETDRS letter score | week 8 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Cirillo | Contact | +41 78 659 89 89 | alvotech.clinical@alvotech.com | |
| Riken Soni | Contact | alvotech.clinical@alvotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 3004 | Recruiting | Budapest | Hungary |
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| Eylea HD (aflibercept HD) | Drug | Patients will receive IVT injections of Eylea HD |
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