A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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ClinicalTrials.gov Identifier: NCT06161584 |
Recruitment Status :
Recruiting
First Posted : December 8, 2023
Last Update Posted : May 31, 2024
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Sponsor:
Apellis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.
Tracking Information | |||||
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First Submitted Date | October 18, 2023 | ||||
First Posted Date | December 8, 2023 | ||||
Last Update Posted Date | May 31, 2024 | ||||
Actual Study Start Date | September 28, 2023 | ||||
Estimated Primary Completion Date | October 2027 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration | ||||
Official Title | A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration | ||||
Brief Summary | A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients residing in the United States who are 60 years or older who have geographic atrophy secondary to age-related macular degeneration | ||||
Condition | Geographic Atrophy | ||||
Intervention | Drug: Pegcetacoplan
Administered intravitreally (IVT) in eyes with geographic atrophy (GA)
Other Name: Syfovre
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Study Groups/Cohorts | Observation
Intervention: Drug: Pegcetacoplan
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
300 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | October 2027 | ||||
Estimated Primary Completion Date | October 2027 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: Eyes are eligible to be included in the study only if all of the following criteria apply. Ocular-specific inclusion criteria apply to the treated eye(s), unless otherwise specified.
Exclusion Criteria: Ocular-specific exclusion criteria apply to the study eye(s) only, unless otherwise specified.
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Sex/Gender |
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Ages | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT06161584 | ||||
Other Study ID Numbers | APL2-GA-411 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Current Responsible Party | Apellis Pharmaceuticals, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Apellis Pharmaceuticals, Inc. | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Apellis Pharmaceuticals, Inc. | ||||
Verification Date | May 2024 |