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This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | Experimental | Patients will receive 1 IVT injection of AVT06 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
|
| Eylea® (Aflibercept) | Experimental | Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVT06 (proposed aflibercept biosimilar) | Drug | Patients will receive IVT injections of AVT06 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA) | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnicni lekarna Sokolov | Sokolov | 35601 | Czechia | |||
| JSC Evex Medical Corporation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40512025 | Derived | Agostini H, Baumane K, Balciuniene VJ, Ozols K, Soni R, Hamdi S, Cirillo S, Rai M, Otto H, Leutz S, Sattar A, Berti F. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025 Jul;25(7):773-787. doi: 10.1080/14712598.2025.2519531. Epub 2025 Jun 17. |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Eylea® (Aflibercept) | Drug | Patients will receive IVT injections of Eylea® |
|
| Tbilisi |
| Georgia |
| Keneikai Hayashi Eye Hospital | Fukuoka | 812 0011 | Japan |
| Riga East University Hospital Clinical Centre "Bikernieki" | Riga | 10006 | Latvia |
| Pauls Stradins Clinical University Hospital SLLC | Riga | 1002 | Latvia |
| Fakultna Nemocnica Trencin | Trenčín | 911 71 | Slovakia |