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Geographic AtrophyNCT06161584

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

An observational study of Geographic Atrophy, run by Apellis Pharmaceuticals, Inc. at 34 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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 Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
Pegcetacoplan
How many people
300 participants
Where
34 sitesUnited States
Study dates
28 Sep 2023to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites
  • Integrated Clinical Research (01-024)

    Abilene, Texas, 79606

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

    Asheville, North Carolina, 28803

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

    Augusta, Georgia, 30909

  • California Retina Consultants (01-026)

    Bakersfield, California, 93309

  • The Retina Care Center (01-023)

    Baltimore, Maryland, 21209

  • Retina Consultants of Texas (01-004)

    Bellaire, Texas, 77401

  • Pacific Northwest Retina (01-036)

    Bellevue, Washington, 98004

  • Mid Atlantic Retina (01-001)

    Bethlehem, Pennsylvania, 18017

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

    Beverly Hills, California, 90211

  • Mid Atlantic Retina Research (01-014)

    Cherry Hill, New Jersey, 08034

  • Mid Atlantic Retina (01-031)

    Cherry Hill, New Jersey, 08906

  • Retina Associates of Cleveland, Inc. (01-017)

    Cleveland, Ohio, 44122

  • Retina Associates of Cleveland, Inc. (01-022)

    Cleveland, Ohio, 44130

  • Texas Retina Associates (01-028)

    Dallas, Texas, 75231

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

    Edina, Minnesota, 55435

  • The Retina Group of Washington (01-021)

    Fairfax, Virginia, 22031

  • Illinois Retina Associates (01-035)

    Fullerton, California, 92835

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

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialist (01-029)

    Hagerstown, Maryland, 21740

  • Colorado Retina Associates, PLLC (01-011)

    Lakewood, Colorado, 80228

  • Georgia Retina (01-032)

    Marietta, Georgia, 30060

  • Retinal Consultants Medical Group Inc (01-008)

    Modesto, California, 95356

  • Tennessee Retina (01-033)

    Nashville, Tennessee, 37203

  • Illinois Retina Associates (01-037)

    Oak Park, Illinois, 60304

  • OCLI Research Department (01-007)

    Oceanside, New York, 11572

  • Retina Specialty Institute (01-019)

    Pensacola, Florida, 32503

  • Retina Consultants San Diego Inc. (01-018)

    Poway, California, 92064

  • Black Hills Regional Eye Institute (01-010)

    Rapid City, South Dakota, 57701

  • California Retina Consultants (01-027)

    Santa Barbara, California, 93103

  • Retina Consultants of Texas (01-003)

    The Woodlands, Texas, 77384

  • Bay Area Retina Associates (01-005)

    Walnut Creek, California, 94598

  • Long Island Vitreoretinal Consultants (01-013)

    Westbury, New York, 11590

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

    York, Pennsylvania, 17402

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

    Youngstown, Ohio, 44505

Other trials in United States

About this study

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

Being tested
Pegcetacoplan
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PegcetacoplanDrug

    Also called Syfovre

    Administered intravitreally (IVT) in eyes with geographic atrophy (GA)

Study groups in NCT06161584
Study groupRoleWhat they receive
ObservationNot described
Receives: Drug: Pegcetacoplan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information

    Measured: Up to 36 months

  2. Incidence of other events of interest

    Measured: Up to 36 months

Secondary outcomes (11)
  1. Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes

    Measured: Up to 36 months

  2. If only one eye is treated, the criteria for determination of the eye to be treated

    Measured: Up to 36 months

  3. The treatment interval (mean days between injections) over time

    Measured: Up to 36 months

  4. 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

    Measured: Up to 36 months

  5. The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned

    Measured: Up to 36 months

  6. The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months

    Measured: Up to 36 months

  7. The treatment discontinuation and/or switching to other agents approved for treatment of GA

    Measured: Up to 36 months

  8. The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice

    Measured: Up to 36 months

  9. The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections

    Measured: Up to 36 months

  10. The number of anti-VEGF injections per month from diagnosis of eAMD

    Measured: Up to 36 months

  11. The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start28 Sep 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161584
Sponsor's protocol ID
APL2-GA-411
Status last verified
May 2026
First submitted
18 Oct 2023
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Geographic Atrophy, run by Apellis Pharmaceuticals, Inc. at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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