Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Pegcetacoplan
Clinical Study ID
Ages > 60 All Genders
Study Summary
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:
Nonsubfoveal lesion(s)
GA lesion visualized in its entirety on the macula-centered OCT image and notcontiguous 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
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
Connect with a study center
California Retina Consultants
Bakersfield, California 93309
United StatesActive - Recruiting
California Retina Consultants (01-026)
Bakersfield, California 93309
United StatesActive - Recruiting
Retina-Vitreous Associates Medical Group (01-020)
Beverly Hills, California 90211
United StatesActive - Recruiting
Illinois Retina Associates (01-035)
Fullerton, California 92835
United StatesActive - Recruiting
Retinal Consultants Medical Group Inc (01-008)
Modesto, California 95356
United StatesActive - Recruiting
Retina Consultants San Diego Inc. (01-018)
Poway, California 92064
United StatesActive - Recruiting
California Retina Consultants (01-027)
Santa Barbara, California 93103
United StatesActive - Recruiting
Bay Area Retina Associates (01-005)
Walnut Creek, California 94598
United StatesActive - Recruiting
Colorado Retina Associates, PLLC (01-011)
Lakewood, Colorado 80228
United StatesActive - Recruiting
Retina Specialty Institute (01-019)
Pensacola, Florida 32503
United StatesActive - Recruiting
South East Retina Center, PC (01-030)
Augusta, Georgia 30909
United StatesActive - Recruiting
Georgia Retina (01-032)
Marietta, Georgia 30060
United StatesActive - Recruiting
Illinois Retina Associates (01-037)
Oak Park, Illinois 60304
United StatesActive - Recruiting
The Retina Care Center (01-023)
Baltimore, Maryland 21209
United StatesActive - Recruiting
Cumberland Valley Retina Consultants, P.C. (01-002)
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Mid Atlantic Retina Specialist (01-029)
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Retina Consultants of Minnesota, PLLC (01-025)
Edina, Minnesota 55435
United StatesActive - Recruiting
Mid Atlantic Retina (01-031)
Cherry Hill, New Jersey 08906
United StatesActive - Recruiting
Mid Atlantic Retina Research (01-014)
Cherry Hill, New Jersey 08034
United StatesActive - Recruiting
OCLI Research Department (01-007)
Oceanside, New York 11572
United StatesActive - Recruiting
Long Island Vitreoretinal Consultants (01-013)
Westbury, New York 11590
United StatesActive - Recruiting
Western Carolina Retinal Associates, PA (01-009)
Asheville, North Carolina 28803
United StatesActive - Recruiting
Retina Associates of Cleveland, Inc. (01-017)
Cleveland, Ohio 44122
United StatesActive - Recruiting
Retina Associates of Cleveland, Inc. (01-022)
Cleveland, Ohio 44130
United StatesActive - Recruiting
Retina Associates of Cleveland, Inc. (01-016)
Youngstown, Ohio 44505
United StatesActive - Recruiting
Mid Atlantic Retina (01-001)
Bethlehem, Pennsylvania 18017
United StatesActive - Recruiting
The Retina Care Center (01-034) - Satellite Site
York, Pennsylvania 17402
United StatesActive - Recruiting
Black Hills Regional Eye Institute (01-010)
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Tennessee Retina (01-033)
Nashville, Tennessee 37203
United StatesActive - Recruiting
Integrated Clinical Research (01-024)
Abilene, Texas 79606
United StatesActive - Recruiting
Retina Consultants of Texas (01-004)
Bellaire, Texas 77401
United StatesActive - Recruiting
Texas Retina Associates (01-028)
Dallas, Texas 75231
United StatesActive - Recruiting
Retina Consultants of Texas (01-003)
The Woodlands, Texas 77384
United StatesActive - Recruiting
The Retina Group of Washington (01-021)
Fairfax, Virginia 22031
United StatesActive - Recruiting
Pacific Northwest Retina (01-036)
Bellevue, Washington 98004
United StatesActive - Recruiting
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