Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration
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ClinicalTrials.gov Identifier: NCT03525600 |
Recruitment Status :
Completed
First Posted : May 15, 2018
Results First Posted : June 18, 2023
Last Update Posted : June 18, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | April 20, 2018 | ||||
First Posted Date ICMJE | May 15, 2018 | ||||
Results First Submitted Date ICMJE | May 24, 2023 | ||||
Results First Posted Date ICMJE | June 18, 2023 | ||||
Last Update Posted Date | June 18, 2023 | ||||
Actual Study Start Date ICMJE | August 31, 2018 | ||||
Actual Primary Completion Date | June 21, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 [ Time Frame: Baseline (screening) and Month 12 ] The GA lesion area was measured by a quantified central reading center based on FAF images. LS mean was calculated using a mixed effect model for repeated measure (MMRM) model. Baseline was defined as the last available, non-missing observation prior to first study drug administration.
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Original Primary Outcome Measures ICMJE |
Change From Baseline to Month 12 in total area of GA Lesions as Measured by Fundus Autofluorescence (FAF) [ Time Frame: Baseline, 12 months ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Incidence and severity of ocular and systemic treatment-emergent adverse events. [ Time Frame: 24 months ] | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration | ||||
Official Title ICMJE | A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) | ||||
Brief Summary | This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Geographic Atrophy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 ICMJE | Completed | ||||
Actual Enrollment ICMJE |
621 | ||||
Original Estimated Enrollment ICMJE |
600 | ||||
Actual Study Completion Date ICMJE | June 20, 2022 | ||||
Actual Primary Completion Date | June 21, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be selected as the study eye. Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.
Exclusion Criteria: Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Israel, Italy, New Zealand, Poland, Puerto Rico, Spain, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03525600 | ||||
Other Study ID Numbers ICMJE | APL2-303 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Apellis Pharmaceuticals, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Apellis Pharmaceuticals, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Apellis Pharmaceuticals, Inc. | ||||
Verification Date | May 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |