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This Phase II study is designed to evaluate the efficacy and safety of AL-001 ophthalmic injection in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will be randomized in Cohorts 1 and 2 to receive AL-001 administered via suprachoroidal space injection, Cohort 3 to receive Aflibercept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-001 Dose 1 | Experimental | Injection of dose 1 |
|
| AL-001 Dose 2 | Experimental | Injection of dose 2 |
|
| Aflibercept | Active Comparator | Intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-001 | Drug | Administered via suprachoroidal space injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of AL-001 on BCVA | Change in BCVA | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Incidence of adverse events (AEs) and serious adverse events (SAEs) | Week 56 |
| Evaluate the effect of AL-001 on central retinal thickness (CRT) | Mean change from baseline in CRT as measured |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anlong Bio | Contact | +86-010-80414166 | info@anlongbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Hospital | Beijing | China |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Aflibercept | Drug | Intravitreal injection |
|
| Week 56 |