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

Geographic Atrophy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161584
• Other study ID #: APL2-GA-411
• Status: Recruiting
• Start date: September 28, 2023
• Est. completion date: October 2027

Study information

• Verified date: February 2024
• Source: Apellis Pharmaceuticals, Inc.
• Contact: Apellis Clinical Trial Information Line
• Phone: 617-977-5700
• Email: clinicaltrials[@]apellis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 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 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 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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• Pegcetacoplan
Administered intravitreally (IVT) in eyes with geographic atrophy (GA)

Locations

Country	Name	City	State
United States	Integrated Clinical Research (01-024)	Abilene	Texas
United States	Western Carolina Retinal Associates, PA (01-009)	Asheville	North Carolina
United States	South East Retina Center, PC (01-030)	Augusta	Georgia
United States	California Retina Consultants (01-026)	Bakersfield	California
United States	The Retina Care Center (01-023)	Baltimore	Maryland
United States	Retina Consultants of Texas (01-004)	Bellaire	Texas
United States	Mid Atlantic Retina (01-001)	Bethlehem	Pennsylvania
United States	Retina-Vitreous Associates Medical Group (01-020)	Beverly Hills	California
United States	Mid Atlantic Retina (01-031)	Cherry Hill	New Jersey
United States	Retina Associates of Cleveland, Inc. (01-017)	Cleveland	Ohio
United States	Retina Associates of Cleveland, Inc. (01-022)	Cleveland	Ohio
United States	Texas Retina Associates (01-028)	Dallas	Texas
United States	Retina Consultants of Minnesota, PLLC (01-025)	Edina	Minnesota
United States	The Retina Group of Washington (01-021)	Fairfax	Virginia
United States	Cumberland Valley Retina Consultants, P.C. (01-002)	Hagerstown	Maryland
United States	Colorado Retina Associates, PLLC (01-011)	Lakewood	Colorado
United States	Georgia Retina (01-032)	Marietta	Georgia
United States	Retinal Consultants Medical Group Inc (01-008)	Modesto	California
United States	Tennessee Retina (01-033)	Nashville	Tennessee
United States	OCLI Research Department (01-007)	Oceanside	New York
United States	Retina Specialty Institute (01-019)	Pensacola	Florida
United States	Retina Consultants San Diego Inc. (01-018)	Poway	California
United States	Black Hills Regional Eye Institute (01-010)	Rapid City	South Dakota
United States	California Retina Consultants (01-027)	Santa Barbara	California
United States	Retina Consultants of Texas (01-003)	The Woodlands	Texas
United States	Bay Area Retina Associates (01-005)	Walnut Creek	California
United States	Long Island Vitreoretinal Consultants (01-013)	Westbury	New York
United States	Retina Associates of Cleveland, Inc. (01-016)	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Apellis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information		Up to 36 months
Primary	Incidence of other events of interest		Up to 36 months
Secondary	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
Secondary	If only one eye is treated, the criteria for determination of the eye to be treated		Up to 36 months
Secondary	The treatment interval (mean days between injections) over time		Up to 36 months
Secondary	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
Secondary	The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned		Up to 36 months
Secondary	The duration of persistence on treatment: continuous medication usage until a gap of =3 months		Up to 36 months
Secondary	The treatment discontinuation and/or switching to other agents approved for treatment of GA		Up to 36 months
Secondary	The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice		Up to 36 months
Secondary	The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections		Up to 36 months
Secondary	The number of anti-VEGF injections per month from diagnosis of eAMD		Up to 36 months
Secondary	The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan		Up to 36 months