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
1 other identifier
observational
300
1 country
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2023
CompletedFirst Submitted
Initial submission to the registry
October 18, 2023
CompletedFirst Posted
Study publicly available on registry
December 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 6, 2026
May 1, 2025
3.7 years
October 18, 2023
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information
Up to 36 months
Incidence of other events of interest
Up to 36 months
Secondary Outcomes (11)
Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes
Up to 36 months
If only one eye is treated, the criteria for determination of the eye to be treated
Up to 36 months
The treatment interval (mean days between injections) over time
Up to 36 months
The frequency of imaging on treated eyes (color fundus photography, spectral domain optical coherence tomography [SD-OCT], fundus autofluorescence, optical coherence tomography angiography [OCT-A
Up to 36 months
The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned
Up to 36 months
- +6 more secondary outcomes
Study Arms (1)
Observation
Interventions
Administered intravitreally (IVT) in eyes with geographic atrophy (GA)
Eligibility Criteria
Patients residing in the United States who are 60 years or older who have geographic atrophy secondary to age-related macular degeneration
You may qualify if:
- Eyes that are naive to treatment with pegcetacoplan that are prescribed pegcetacoplan per routine clinical practice according to approved pegcetacoplan prescribing information (ie, the clinical decision to treat with pegcetacoplan must be made before study participation is discussed with the patient)
- Patient age ≥60 years
- Visual acuity better than 20/200 on Snellen chart
- Clinical diagnosis of GA of the macula secondary to AMD in one or both eyes as determined by the investigator using OCT and/or FAF imaging
- GA lesion meeting the following criteria as determined by the investigator's assessment of Spectralis OCT and/or FAF images at screening:
- Nonsubfoveal lesion(s)
- GA lesion visualized in its entirety on the macula-centered OCT image and not contiguous with any areas of peripapillary atrophy
- Adequate clarity of ocular media and adequate pupillary dilation and fixation to permit the collection of good quality images as determined by the investigator
- Patient willing and able to give informed consent and to comply with the study procedures and assessments
You may not qualify if:
- GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like Plaquenil maculopathy in either eye
- Active, suspected, or history of intraocular inflammation in either eye at screening or on day 1
- Any history of or active choroidal neovascularization associated with AMD or any other cause, including any evidence of retinal pigment epithelial tears or rips in SD OCT imaging
- Any prior treatment with anti-VEGF agents
- Intraocular surgery (including lens replacement surgery) within 3 months prior to screening
- History of laser therapy in the macular region
- Any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period
- Any contraindication to IVT injection
- Current ocular or periocular infection in either eye
- Intravitreal medical device placement
- Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up unlikely or would make the patient an unsafe study candidate
- Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution
- History or current use of brolucizumab and/or pharmacological treatments that gain approval for the treatment of GA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
California Retina Consultants (01-026)
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group (01-020)
Beverly Hills, California, 90211, United States
Illinois Retina Associates (01-035)
Fullerton, California, 92835, United States
Retinal Consultants Medical Group Inc (01-008)
Modesto, California, 95356, United States
Retina Consultants San Diego Inc. (01-018)
Poway, California, 92064, United States
California Retina Consultants (01-027)
Santa Barbara, California, 93103, United States
Bay Area Retina Associates (01-005)
Walnut Creek, California, 94598, United States
Colorado Retina Associates, PLLC (01-011)
Lakewood, Colorado, 80228, United States
Retina Specialty Institute (01-019)
Pensacola, Florida, 32503, United States
South East Retina Center, PC (01-030)
Augusta, Georgia, 30909, United States
Georgia Retina (01-032)
Marietta, Georgia, 30060, United States
Illinois Retina Associates (01-037)
Oak Park, Illinois, 60304, United States
The Retina Care Center (01-023)
Baltimore, Maryland, 21209, United States
Cumberland Valley Retina Consultants, P.C. (01-002)
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialist (01-029)
Hagerstown, Maryland, 21740, United States
Retina Consultants of Minnesota, PLLC (01-025)
Edina, Minnesota, 55435, United States
Mid Atlantic Retina Research (01-014)
Cherry Hill, New Jersey, 08034, United States
Mid Atlantic Retina (01-031)
Cherry Hill, New Jersey, 08906, United States
OCLI Research Department (01-007)
Oceanside, New York, 11572, United States
Long Island Vitreoretinal Consultants (01-013)
Westbury, New York, 11590, United States
Western Carolina Retinal Associates, PA (01-009)
Asheville, North Carolina, 28803, United States
Retina Associates of Cleveland, Inc. (01-017)
Cleveland, Ohio, 44122, United States
Retina Associates of Cleveland, Inc. (01-022)
Cleveland, Ohio, 44130, United States
Retina Associates of Cleveland, Inc. (01-016)
Youngstown, Ohio, 44505, United States
Mid Atlantic Retina (01-001)
Bethlehem, Pennsylvania, 18017, United States
The Retina Care Center (01-034) - Satellite Site
York, Pennsylvania, 17402, United States
Black Hills Regional Eye Institute (01-010)
Rapid City, South Dakota, 57701, United States
Tennessee Retina (01-033)
Nashville, Tennessee, 37203, United States
Integrated Clinical Research (01-024)
Abilene, Texas, 79606, United States
Retina Consultants of Texas (01-004)
Bellaire, Texas, 77401, United States
Texas Retina Associates (01-028)
Dallas, Texas, 75231, United States
Retina Consultants of Texas (01-003)
The Woodlands, Texas, 77384, United States
The Retina Group of Washington (01-021)
Fairfax, Virginia, 22031, United States
Pacific Northwest Retina (01-036)
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2023
First Posted
December 8, 2023
Study Start
September 28, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 6, 2026
Record last verified: 2025-05