Geographic Atrophy Secondary to Age-related Macular DegenerationPhase 3NCT07214740
Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe
A Phase 3 study testing APL-2, Pegcetacoplan in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Apellis Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- What is being tested?
- APL-2, Pegcetacoplan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Oct 2025to 12 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- Participants must be aged at least 60 years and have a diagnosis of GA secondary to AMD.
- Participants must have adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images in the study eye as determined by the retina specialist.
- Study eye must be deemed to be indicated for IVT pegcetacoplan therapy at the discretion of the retina specialist.
- Female participants must be women of nonchildbearing potential, defined as postmenopausal women with 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to screening/baseline. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
- Male participants must be surgically sterile or must agree to use protocol-defined highly effective methods of contraception and to refrain from donating sperm from screening through the duration of the study and for 90 days after their dose of study drug.
- Participants must be willing and able to provide informed consent and comply with the study visit schedule and study-related procedures/requirements.
Who cannot join
- Retinal atrophy secondary to a condition other than AMD, such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like plaquenil maculopathy, in either eye.
- Any history or active CNV associated with AMD or any other cause, including any evidence of RPE rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography imaging as assessed by the retina specialist.
- Presence of an active ocular disease in the study eye 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, or uncontrolled glaucoma/ocular hypertension); benign conditions in the opinion of the investigator, such as peripheral retina dystrophy, are not exclusionary.
- IOP >21 mm Hg in the study eye at the screening/baseline visit.
- Participants who have legal blindness or worse vision in study eye (ie, best-corrected visual acuity [BCVA] of ≤35 Early Treatment Diabetic Retinopathy Study letters).
- History of laser therapy in the macular region of study eye.
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- Any intraocular surgery in the study eye at any time during the past 3 months.
- 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 prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational, including steroids) in the study eye.
- Active, suspected, or history of IOI in either eye at the screening/baseline visit.
- Any contraindication to IVT injection, including current ocular or periocular infection.
- Current systemic infectious disease or a therapy for active infectious disease.
- History of IVT injection in the study eye within 90 days or 5 half-lives of the product (other than IVT pegcetacoplan), whichever is longer, prior to the screening/baseline visit
- Participation in an investigational product or medical device study (other than IVT pegcetacoplan studies) within 90 days or 5 half-lives of the product, whichever is longer, prior to the screening/baseline visit.
- Known hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution.
- Pregnancy or breastfeeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Austin Retina Associates
Austin, Texas, 78705
California Retina Consultants
Bakersfield, California, 93309
Retina Consultants of Texas
Katy, Texas, 77494
California Retina Consultants
Oxnard, California, 93036
Retina Consultants of Texas
Woodland, Texas, 77384
About this study
Official title: A Phase 3B, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety of Pegcetacoplan in a Prefilled Syringe in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS)
- Being tested
- APL-2, Pegcetacoplan
- Keywords
- Geographic Atrophy, Age-Related Macular Degeneration
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL-2, PegcetacoplanDrug
Complement (C3) Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Pegcetacoplan, 15 mg/100 μL (single dose), intravitreal injection via prefilled syringe | Experimental | This is a 30-day, phase 3b, single-arm, open-label, multicenter study to evaluate the safety of IVT pegcetacoplan administered via PFS in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study consists of a screening/baseline visit at day 1, a follow-up call at day 7, and an end of study visit at day 30. Receives: Drug: APL-2, Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye
Measured: Up to Day 30
Secondary outcomes (1)
The number of IVT pegcetacoplan injections successfully administered using PFS as reported by retina specialists immediately following the injection
Measured: At Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start24 Oct 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic Atrophy Secondary to Age-related Macular DegenerationStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214740
- Sponsor's protocol ID
- APL2-GA-317
- Status last verified
- Dec 2025
- First submitted
- 6 Oct 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3B, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety of Pegcetacoplan in a Prefilled Syringe in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07214740
- Acronym / sponsor ID
- APL2-GA-317
- Keywords
- Geographic Atrophy, Age-Related Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 9 Oct 2025 (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.
This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegcetacoplan, 15 mg/100 μL (single dose), intravitreal injection via prefilled syringe | Experimental | Drug: APL-2, PegcetacoplanThis is a 30-day, phase 3b, single-arm, open-label, multicenter study to evaluate the safety of IVT pegcetacoplan administered via PFS in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study consists of a screening/baseline visit at day 1, a follow-up call at day 7, and an end of study visit at day 30. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be aged at least 60 years and have a diagnosis of GA secondary to AMD.
- Participants must have adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images in the study eye as determined by the retina specialist.
- Study eye must be deemed to be indicated for IVT pegcetacoplan therapy at the discretion of the retina specialist.
- Female participants must be women of nonchildbearing potential, defined as postmenopausal women with 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to screening/baseline. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
- Male participants must be surgically sterile or must agree to use protocol-defined highly effective methods of contraception and to refrain from donating sperm from screening through the duration of the study and for 90 days after their dose of study drug.
Key exclusion criteria (16 listed)
- Retinal atrophy secondary to a condition other than AMD, such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like plaquenil maculopathy, in either eye.
- Any history or active CNV associated with AMD or any other cause, including any evidence of RPE rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography imaging as assessed by the retina specialist.
- Presence of an active ocular disease in the study eye 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, or uncontrolled glaucoma/ocular hypertension); benign conditions in the opinion of the investigator, such as peripheral retina dystrophy, are not exclusionary.
- IOP >21 mm Hg in the study eye at the screening/baseline visit.
- Participants who have legal blindness or worse vision in study eye (ie, best-corrected visual acuity [BCVA] of ≤35 Early Treatment Diabetic Retinopathy Study letters).
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 |
|---|---|---|
| APL-2, PegcetacoplanComplement (C3) Inhibitor | Drug | Pegcetacoplan, 15 mg/100 μL (single dose), intravitreal injection via prefilled syringe |
Primary outcome
To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye
Time frame: Up to Day 30
1 secondary outcome
The number of IVT pegcetacoplan injections successfully administered using PFS as reported by retina specialists immediately following the injection
Time frame: At Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APL-2, Pegcetacoplan in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Apellis Pharmaceuticals, Inc. at 5 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?
The sponsor lists 6 inclusion and 16 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate safety and tolerability of intravitreal (IVT) pegcetacoplan administered via PFS by assessing incidence of ocular treatment-emergent adverse events (TEAEs) in the study eye (time frame: Up to Day 30). 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 17 Dec 2025.