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The objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose comparison | Active Comparator |
| |
| Dose comparison | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avacincaptad Pegol | Drug | intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes | 1 year |
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Inclusion Criteria:
Dry AMD (drusen and/or geographic atrophy) in both eyes
Exclusion Criteria:
Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past twelve (12) weeks.
History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.
Any of the following underlying diseases including:
Women who are pregnant or nursing. Known serious allergies to the fluorescein dye used in angiography or to the components of the ARC1905 formulation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthotech | New York | New York | United States |
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| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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