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
- Registration Number
- NCT06161584
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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.
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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)
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Patient age ≥60 years
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Visual acuity better than 20/200 on Snellen chart
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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
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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
- Presence of any pattern of hyperautofluorescence in the junctional zone of GA; absence of hyperautofluorescence (ie, pattern = none) exclusionary
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Adequate clarity of ocular media and adequate pupillary dilation and fixation to permit the collection of good quality images as determined by the investigator
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Patient willing and able to give informed consent and to comply with the study procedures and assessments
Ocular-specific exclusion criteria apply to the study eye(s) only, unless otherwise specified.
- 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
- Presence of an active ocular disease that in the opinion of the investigator compromises or confounds visual function, including but not limited to uveitis and other macular diseases (eg, clinically significant epiretinal membrane, full thickness macular hole, uncontrolled glaucoma/ocular hypertension). Conditions that in the opinion of the investigator are benign, such as peripheral retina dystrophy, are not exclusionary
- 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
- Aphakia or absence of the posterior capsule. Note: Yttrium aluminum garnet laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
- 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
- Participation in any prior or current systemic experimental treatment within 6 weeks or 5 half lives of the active ingredient (whichever is longer) prior to the start of study treatment or in any other investigational treatments specific to GA. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observation Pegcetacoplan -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method If only one eye is treated, the criteria for determination of the eye to be treated 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 number of anti-VEGF injections per month from diagnosis of eAMD Up to 36 months The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan Up to 36 months The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months Up to 36 months 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 The treatment interval (mean days between injections) over time 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 The treatment discontinuation and/or switching to other agents approved for treatment of GA Up to 36 months The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice Up to 36 months The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections Up to 36 months
Trial Locations
- Locations (31)
Retinal Consultants Medical Group Inc (01-008)
🇺🇸Modesto, California, United States
Retina-Vitreous Associates Medical Group (01-020)
🇺🇸Beverly Hills, California, United States
Long Island Vitreoretinal Consultants (01-013)
🇺🇸Westbury, New York, United States
Retina Consultants San Diego Inc. (01-018)
🇺🇸Poway, California, United States
Colorado Retina Associates, PLLC (01-011)
🇺🇸Lakewood, Colorado, United States
Retina Specialty Institute (01-019)
🇺🇸Pensacola, Florida, United States
Retina Consultants of Texas (01-004)
🇺🇸Bellaire, Texas, United States
Retina Consultants of Minnesota, PLLC (01-025)
🇺🇸Edina, Minnesota, United States
Mid Atlantic Retina (01-031)
🇺🇸Cherry Hill, New Jersey, United States
OCLI Research Department (01-007)
🇺🇸Oceanside, New York, United States
California Retina Consultants (01-026)
🇺🇸Bakersfield, California, United States
Georgia Retina (01-032)
🇺🇸Marietta, Georgia, United States
California Retina Consultants (01-027)
🇺🇸Santa Barbara, California, United States
South East Retina Center, PC (01-030)
🇺🇸Augusta, Georgia, United States
Retina Associates of Cleveland, Inc. (01-016)
🇺🇸Youngstown, Ohio, United States
Retina Consultants of Texas (01-003)
🇺🇸The Woodlands, Texas, United States
The Retina Group of Washington (01-021)
🇺🇸Fairfax, Virginia, United States
The Retina Care Center (01-023)
🇺🇸Baltimore, Maryland, United States
Cumberland Valley Retina Consultants, P.C. (01-002)
🇺🇸Hagerstown, Maryland, United States
Mid Atlantic Retina Specialist (01-029)
🇺🇸Hagerstown, Maryland, United States
Tennessee Retina (01-033)
🇺🇸Nashville, Tennessee, United States
Retina Associates of Cleveland, Inc. (01-017)
🇺🇸Cleveland, Ohio, United States
Retina Associates of Cleveland, Inc. (01-022)
🇺🇸Cleveland, Ohio, United States
Bay Area Retina Associates (01-005)
🇺🇸Walnut Creek, California, United States
The Retina Care Center (01-034) - Satellite Site
🇺🇸York, Pennsylvania, United States
Mid Atlantic Retina Research (01-014)
🇺🇸Cherry Hill, New Jersey, United States
Western Carolina Retinal Associates, PA (01-009)
🇺🇸Asheville, North Carolina, United States
Mid Atlantic Retina (01-001)
🇺🇸Bethlehem, Pennsylvania, United States
Black Hills Regional Eye Institute (01-010)
🇺🇸Rapid City, South Dakota, United States
Integrated Clinical Research (01-024)
🇺🇸Abilene, Texas, United States
Texas Retina Associates (01-028)
🇺🇸Dallas, Texas, United States