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

Status: Active_not_recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

⁃ 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 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

Locations
United States
California
California Retina Consultants (01-026)
Bakersfield
Retina-Vitreous Associates Medical Group (01-020)
Beverly Hills
Illinois Retina Associates (01-035)
Fullerton
Retinal Consultants Medical Group Inc (01-008)
Modesto
Retina Consultants San Diego Inc. (01-018)
Poway
California Retina Consultants (01-027)
Santa Barbara
Bay Area Retina Associates (01-005)
Walnut Creek
Colorado
Colorado Retina Associates, PLLC (01-011)
Lakewood
Florida
Retina Specialty Institute (01-019)
Pensacola
Georgia
South East Retina Center, PC (01-030)
Augusta
Georgia Retina (01-032)
Marietta
Illinois
Illinois Retina Associates (01-037)
Oak Park
Maryland
The Retina Care Center (01-023)
Baltimore
Cumberland Valley Retina Consultants, P.C. (01-002)
Hagerstown
Mid Atlantic Retina Specialist (01-029)
Hagerstown
Minnesota
Retina Consultants of Minnesota, PLLC (01-025)
Edina
North Carolina
Western Carolina Retinal Associates, PA (01-009)
Asheville
New Jersey
Mid Atlantic Retina (01-031)
Cherry Hill
Mid Atlantic Retina Research (01-014)
Cherry Hill
New York
OCLI Research Department (01-007)
Oceanside
Long Island Vitreoretinal Consultants (01-013)
Westbury
Ohio
Retina Associates of Cleveland, Inc. (01-017)
Cleveland
Retina Associates of Cleveland, Inc. (01-022)
Cleveland
Retina Associates of Cleveland, Inc. (01-016)
Youngstown
Pennsylvania
Mid Atlantic Retina (01-001)
Bethlehem
The Retina Care Center (01-034) - Satellite Site
York
South Dakota
Black Hills Regional Eye Institute (01-010)
Rapid City
Tennessee
Tennessee Retina (01-033)
Nashville
Texas
Integrated Clinical Research (01-024)
Abilene
Retina Consultants of Texas (01-004)
Bellaire
Texas Retina Associates (01-028)
Dallas
Retina Consultants of Texas (01-003)
The Woodlands
Virginia
The Retina Group of Washington (01-021)
Fairfax
Washington
Pacific Northwest Retina (01-036)
Bellevue
Time Frame
Start Date: 2023-09-28
Completion Date: 2028-06
Participants
Target number of participants: 300
Treatments
Observation
Sponsors
Leads: Apellis Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov