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.
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:
- 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
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
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
- Conditions
- Geographic Atrophy
- 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 group | Role | What they receive |
|---|---|---|
| Observation | Not described Receives: Drug: Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Incidence of other events of interest
Measured: Up to 36 months
Secondary outcomes (11)
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
If only one eye is treated, the criteria for determination of the eye to be treated
Measured: Up to 36 months
The treatment interval (mean days between injections) over time
Measured: Up to 36 months
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
The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned
Measured: Up to 36 months
The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months
Measured: Up to 36 months
The treatment discontinuation and/or switching to other agents approved for treatment of GA
Measured: Up to 36 months
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
The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections
Measured: Up to 36 months
The number of anti-VEGF injections per month from diagnosis of eAMD
Measured: Up to 36 months
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.
- First posted8 Dec 2023
- Study start28 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06161584
- Acronym / sponsor ID
- APL2-GA-411
- Conditions
- Geographic Atrophy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Drug: Pegcetacoplan |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegcetacoplanAlso: SyfovreAdministered intravitreally (IVT) in eyes with geographic atrophy (GA) | Drug | Observation |
Primary outcome
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
Incidence of other events of interest
Time frame: Up to 36 months
11 secondary outcomes
Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes
Time frame: Up to 36 months
If only one eye is treated, the criteria for determination of the eye to be treated
Time frame: Up to 36 months
The treatment interval (mean days between injections) over time
Time frame: Up to 36 months
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
Time frame: Up to 36 months
The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned
Time frame: Up to 36 months
The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months
Time frame: Up to 36 months
The treatment discontinuation and/or switching to other agents approved for treatment of GA
Time frame: Up to 36 months
The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice
Time frame: Up to 36 months
The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections
Time frame: Up to 36 months
The number of anti-VEGF injections per month from diagnosis of eAMD
Time frame: Up to 36 months
The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Related trials for Geographic Atrophy
Active, not recruitingObservational study
A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
Geographic Atrophy, Macular Degeneration
Enrolling by invitation
Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
Geographic Atrophy
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Geographic Atrophy Secondary to Age-Related Macular Degeneration
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration
RecruitingPhase 2
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Geographic Atrophy of the Macula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
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.