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Syfovre safety check: Real-World study tracks eye drug in 300 patients

NCT ID NCT06161584

Disease control Sponsor: Apellis Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how safe and tolerable the drug pegcetacoplan (Syfovre) is for people with geographic atrophy, a form of advanced age-related macular degeneration that causes vision loss. About 300 patients who are already prescribed the drug by their doctor will be followed to track side effects and how the drug is used in real life. The goal is to understand treatment patterns and safety outside of a controlled clinical trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients residing in the United States who are 60 years or older who have geographic atrophy secondary to age-related macular degeneration

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Geographic atrophy

Contacts and locations

Locations

  • Bay Area Retina Associates (01-005)

    Walnut Creek, California, 94598, United States

  • Black Hills Regional Eye Institute (01-010)

    Rapid City, South Dakota, 57701, United States

  • California Retina Consultants (01-026)

    Bakersfield, California, 93309, United States

  • California Retina Consultants (01-027)

    Santa Barbara, California, 93103, United States

  • Colorado Retina Associates, PLLC (01-011)

    Lakewood, Colorado, 80228, United States

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

    Hagerstown, Maryland, 21740, United States

  • Georgia Retina (01-032)

    Marietta, Georgia, 30060, United States

  • Illinois Retina Associates (01-035)

    Fullerton, California, 92835, United States

  • Illinois Retina Associates (01-037)

    Oak Park, Illinois, 60304, United States

  • Integrated Clinical Research (01-024)

    Abilene, Texas, 79606, United States

  • Long Island Vitreoretinal Consultants (01-013)

    Westbury, New York, 11590, United States

  • Mid Atlantic Retina (01-001)

    Bethlehem, Pennsylvania, 18017, United States

  • Mid Atlantic Retina (01-031)

    Cherry Hill, New Jersey, 08906, United States

  • Mid Atlantic Retina Research (01-014)

    Cherry Hill, New Jersey, 08034, United States

  • Mid Atlantic Retina Specialist (01-029)

    Hagerstown, Maryland, 21740, United States

  • OCLI Research Department (01-007)

    Oceanside, New York, 11572, United States

  • Pacific Northwest Retina (01-036)

    Bellevue, Washington, 98004, United States

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

    Youngstown, Ohio, 44505, 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 Consultants San Diego Inc. (01-018)

    Poway, California, 92064, United States

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

    Edina, Minnesota, 55435, United States

  • Retina Consultants of Texas (01-003)

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Texas (01-004)

    Bellaire, Texas, 77401, United States

  • Retina Specialty Institute (01-019)

    Pensacola, Florida, 32503, United States

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

    Beverly Hills, California, 90211, United States

  • Retinal Consultants Medical Group Inc (01-008)

    Modesto, California, 95356, United States

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

    Augusta, Georgia, 30909, United States

  • Tennessee Retina (01-033)

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates (01-028)

    Dallas, Texas, 75231, United States

  • The Retina Care Center (01-023)

    Baltimore, Maryland, 21209, United States

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

    York, Pennsylvania, 17402, United States

  • The Retina Group of Washington (01-021)

    Fairfax, Virginia, 22031, United States

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

    Asheville, North Carolina, 28803, United States

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