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

Last updated: May 29, 2025
Sponsor: Apellis Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Pegcetacoplan

Clinical Study ID

NCT06161584
APL2-GA-411
  • Ages > 60
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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.

  • Eyes that are naive to treatment with pegcetacoplan that are prescribedpegcetacoplan per routine clinical practice according to approved pegcetacoplanprescribing information (ie, the clinical decision to treat with pegcetacoplan mustbe 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 asdetermined by the investigator using OCT and/or FAF imaging

  • GA lesion meeting the following criteria as determined by the investigator'sassessment of Spectralis OCT and/or FAF images at screening:

  1. Nonsubfoveal lesion(s)

  2. GA lesion visualized in its entirety on the macula-centered OCT image and notcontiguous with any areas of peripapillary atrophy

  3. Presence of any pattern of hyperautofluorescence in the junctional zone of GA;absence of hyperautofluorescence (ie, pattern = none) exclusionary

  • Adequate clarity of ocular media and adequate pupillary dilation and fixation topermit the collection of good quality images as determined by the investigator

  • Patient willing and able to give informed consent and to comply with the studyprocedures and assessments

Exclusion

Exclusion Criteria: 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 roddystrophy, or toxic maculopathies like Plaquenil maculopathy in either eye

  • Active, suspected, or history of intraocular inflammation in either eye at screeningor on day 1

  • Any history of or active choroidal neovascularization associated with AMD or anyother cause, including any evidence of retinal pigment epithelial tears or rips inSD OCT imaging

  • Presence of an active ocular disease that in the opinion of the investigatorcompromises or confounds visual function, including but not limited to uveitis andother macular diseases (eg, clinically significant epiretinal membrane, fullthickness macular hole, uncontrolled glaucoma/ocular hypertension). Conditions thatin 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 toscreening

  • History of laser therapy in the macular region

  • Aphakia or absence of the posterior capsule. Note: Yttrium aluminum garnet laserposterior capsulotomy for posterior capsule opacification done at least 60 daysprior to screening is not exclusionary.

  • Any ocular condition other than GA secondary to AMD that may require surgery ormedical 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 weeksor 5 half lives of the active ingredient (whichever is longer) prior to the start ofstudy treatment or in any other investigational treatments specific to GA. Clinicaltrials solely involving observation, over-the-counter vitamins, supplements, ordiets are not exclusionary

  • Medical or psychiatric conditions that, in the opinion of the investigator, makeconsistent follow-up unlikely or would make the patient an unsafe study candidate

  • Known hypersensitivity to fluorescein sodium for injection or hypersensitivity topegcetacoplan or any of the excipients in pegcetacoplan solution

  • History or current use of brolucizumab and/or pharmacological treatments that gainapproval for the treatment of GA

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Pegcetacoplan
Phase:
Study Start date:
September 28, 2023
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • California Retina Consultants (01-026)

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Retina-Vitreous Associates Medical Group (01-020)

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Illinois Retina Associates (01-035)

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group Inc (01-008)

    Modesto, California 95356
    United States

    Active - Recruiting

  • Retina Consultants San Diego Inc. (01-018)

    Poway, California 92064
    United States

    Active - Recruiting

  • California Retina Consultants (01-027)

    Santa Barbara, California 93103
    United States

    Active - Recruiting

  • Bay Area Retina Associates (01-005)

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Colorado Retina Associates, PLLC (01-011)

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Retina Specialty Institute (01-019)

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • South East Retina Center, PC (01-030)

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Georgia Retina (01-032)

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Illinois Retina Associates (01-037)

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • The Retina Care Center (01-023)

    Baltimore, Maryland 21209
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants, P.C. (01-002)

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Mid Atlantic Retina Specialist (01-029)

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Retina Consultants of Minnesota, PLLC (01-025)

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Mid Atlantic Retina (01-031)

    Cherry Hill, New Jersey 08906
    United States

    Active - Recruiting

  • Mid Atlantic Retina Research (01-014)

    Cherry Hill, New Jersey 08034
    United States

    Active - Recruiting

  • OCLI Research Department (01-007)

    Oceanside, New York 11572
    United States

    Active - Recruiting

  • Long Island Vitreoretinal Consultants (01-013)

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Western Carolina Retinal Associates, PA (01-009)

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Retina Associates of Cleveland, Inc. (01-017)

    Cleveland, Ohio 44122
    United States

    Active - Recruiting

  • Retina Associates of Cleveland, Inc. (01-022)

    Cleveland, Ohio 44130
    United States

    Active - Recruiting

  • Retina Associates of Cleveland, Inc. (01-016)

    Youngstown, Ohio 44505
    United States

    Active - Recruiting

  • Mid Atlantic Retina (01-001)

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • The Retina Care Center (01-034) - Satellite Site

    York, Pennsylvania 17402
    United States

    Active - Recruiting

  • Black Hills Regional Eye Institute (01-010)

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Tennessee Retina (01-033)

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Integrated Clinical Research (01-024)

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Retina Consultants of Texas (01-004)

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Texas Retina Associates (01-028)

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Retina Consultants of Texas (01-003)

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • The Retina Group of Washington (01-021)

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Pacific Northwest Retina (01-036)

    Bellevue, Washington 98004
    United States

    Active - Recruiting

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