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This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegcetacoplan, 15 mg/100 μL (single dose), intravitreal injection via prefilled syringe | Experimental | This is a 30-day, phase 3b, single-arm, open-label, multicenter study to evaluate the safety of IVT pegcetacoplan administered via PFS in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study consists of a screening/baseline visit at day 1, a follow-up call at day 7, and an end of study visit at day 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APL-2, Pegcetacoplan | Drug | Complement (C3) Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye | Up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of IVT pegcetacoplan injections successfully administered using PFS as reported by retina specialists immediately following the injection | At Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| California Retina Consultants |
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000716074 | pegcetacoplan |
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| Oxnard |
| California |
| 93036 |
| United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Retina Consultants of Texas | Woodland | Texas | 77384 | United States |