ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-09-28

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06161584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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: 1. Nonsubfoveal lesion(s) 2. GA lesion visualized in its entirety on the macula-centered OCT image and not contiguous 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 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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:
1. Nonsubfoveal lesion(s)
2. GA lesion visualized in its entirety on the macula-centered OCT image and not contiguous 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 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

* 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

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Apellis Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-28

Study Completion Date2028-06

Study Record Updates

Study Start Date2023-09-28

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Geographic Atrophy