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Geographic Atrophy Secondary to Age-related Macular DegenerationPhase 2NCT07215390

A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio

A Phase 2 study testing APL-3007, pegcetacoplan (APL-2) in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Apellis Pharmaceuticals, Inc. at 78 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Phase 2, Randomized, Placebo-controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 in Combination with Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed with Geographic Atrophy Secondary to Age-Related Macular Degeneration Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
APL-3007, pegcetacoplan (APL-2)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
78 sitesUnited States
Study dates
23 Jun 2025to Nov 2027
Phase
Phase 2
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

Who may be able to join

  • The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with better normal luminance visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be used as the study eye.
  • Aged ≥60 years
  • Clinical diagnosis of GA of the macula secondary to AMD in one or both eyes, as determined by the investigator and confirmed by the reading center
  • NL-BCVA of 50 letters or better using early treatment diabetic retinopathy study (ETDRS) charts (approximately 20/100 Snellen equivalent)
  • 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 investigator
  • Prior treatment for GA in the study eye using Syfovre at 6-8 weeks interval for at least 6 months but no more than 24 months. Participants will be included if the participant has had at least 2 Syfovre injections in the last 6 months before screening.
Show all 22Show fewer
  • The GA lesion in at least 1 eye (designated as the study eye) must meet the following criteria as determined by the central reading center's OCT based RPE assessment of imaging at screening:
  • Total GA area must be ≥2.5 and ≤17.5 mm2 (1-7 disk areas [DA])
  • If GA is multifocal, at least 1 focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 7a
  • The entire GA lesion must be completely visualized in the field of view of the OCT, with the GA RPE lesion border >500 µm from the edge of the imaging window or any areas of peripapillary atrophy.
  • Nonsubfoveal lesion with border of GA lesion not encroaching center of the fovea. Distance of GA RPE lesion from center of the fovea >0 based on OCT imaging.
  • Presence of any pattern of hyperautofluorescence based on FAF imaging in the junctional zone of GA. Absence of hyperautofluorescence (ie, pattern = none) is exclusionary.
  • Documented evidence of vaccination within 5 years prior to screening, or willing to initiate vaccinations at least 14 days prior to dosing against:
  • Streptococcus pneumoniae (with a pneumococcal conjugate vaccine 15 [PCV15] or 20 [PCV20] or with pneumococcal polysaccharide vaccine 23 [PPSV23]),
  • Haemophilus influenzae (type B) (with Hib vaccine),
  • Neisseria meningitidis types A, C, W, and Y (with a quadrivalent meningococcal conjugate vaccine [eg, Menactra or MenQuadfi]), and
  • Neisseria meningitidis type B (with a meningococcal serogroup B vaccine [eg, Bexsero])
  • Female participants must be:
  • Women of non-childbearing potential (WONCBP), or
  • Women of childbearing potential (WOCBP) with a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study (see Section 10.9.5.1)
  • Male participants must be surgically sterile or must agree to use highly effective contraception from screening through the duration of the study
  • Willing and able to provide informed consent and adhere to the study visit schedule and other protocol requirements

Who cannot join

  • Uncontrolled, clinically relevant history of any gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, or cancer
  • History or presence of hepatic cirrhosis or other liver disease that may increase the risk of drug-induced liver injury
  • History or presence of systemic autoimmune disorders, with the exception of well controlled Hashimoto's thyroiditis
  • History of allergy, hypersensitivity, or serious adverse reaction to siRNA therapy or related compounds, or allergy to any of the components of the study drug
  • Clinically meaningful abnormalities on diagnostic and laboratory testing must be adjudicated by the sponsor's medical monitor and include:
  • Cardiac
Show all 39Show fewer
  • Sustained resting heart rate outside of range of 40 to 100 beats/minute, or a heart rhythm that is not sinus rhythm, confirmed on repeat testing within a maximum of 30 minutes, at screening
  • History or evidence of hereditary short QT syndrome
  • Fridericia's corrected QT interval (QTcF) >480 milliseconds, or the PR interval outside the range of 120 to 220 milliseconds, confirmed on repeat testing within a maximum of 30 minutes at screening
  • Any clinically relevant features of acute coronary syndrome (unstable angina, myocardial infarction)
  • Any other ECG parameters outside of age-adjusted normative range
  • Hepatic
  • AST or ALT >1.3 × ULN
  • Total bilirubin >1.1 × ULN
  • Any 2 LFTs >1.1 × ULN
  • Any other LFT parameters outside of age-adjusted normative range
  • Renal
  • Estimated glomerular filtration rate of less than <45 mL/min/m2 as calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD- EPI) creatinine equation for adults
  • Any other renal function parameters outside of age-adjusted normative range
  • History or presence of malignancy (except history of basal or squamous cell carcinoma of the skin) that has not been successfully treated ≥1 year prior to enrollment
  • History or presence of recurrent or unexplained infections, HIV infection, hepatitis B, hepatitis C, or meningococcal infection
  • Participants with fever (defined as temperature >100.4 °F/38 °C) or any acute infection (including COVID-19 infection or infection requiring antibiotic treatment) within 30 days of screening until dosing
  • Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
  • Intention to donate sperm during this study or within 90 days after the last dose of study drug
  • Prior administration of APL-3007
  • Participation in an investigational product or medical device study within 5 half-lives of the investigational product before the screening visit
  • Has poor peripheral venous access or any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection that would interfere with SC injections or assessments of injection local tolerability
  • Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator or medical monitor(s), unacceptably increase the participant's risk by participating in the study
  • Has received a live vaccination (excluding seasonal flu vaccination) within 30 days prior to the first dose administration
  • Women who are pregnant or breastfeeding
  • Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or would make the participant an unsafe study candidate
  • Ocular specific exclusion criteria apply to the study eye 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
  • Any history of CNV (active or nonexudative/quiescent) in the study eye associated with AMD or any other cause, including any evidence of RPE rips, double layer sign, or evidence of neovascularization anywhere based on SD-OCT imaging and fluorescein angiography as assessed by the reading center
  • Presence of an active ocular disease that, in the opinion of the investigator, compromises or confounds visual function, including but not limited to, uveitis, 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.
  • History of IVT injection in the study eye within 3 months prior to the screening visit, with the exception of IVT Syfovre
  • History of any previous investigational product for GA treatment in either eye within 3 months (or 5 half-lives of the investigational drug, whichever is longer) prior to the screening visit
  • History of laser therapy in the macular region
  • 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

Trial locations and contacts

78 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Apellis Clinical Trial Information Line contact

617-977-5700

clinicaltrials@apellis.com

78 sites in 1 country

United States78 sites, 78 recruiting

  • Retina Consultants of Texas - Abilene (01035)

    Abilene, Texas, 79606

    Recruiting

  • Vision Research Center Eye Associates of New Mexico (01023)

    Albuquerque, New Mexico, 87109

    Recruiting

  • Southeast Retina Center

    Augusta, Georgia, 30909

    Recruiting

  • Austin Retina Associates

    Austin, Texas, 78705

    Recruiting

  • California Retina Consultants (CRC) - Bakersfield Office

    Bakersfield, California, 93309

    Recruiting

  • The Retina Care Center

    Baltimore, Maryland, 21209

    Recruiting

  • ClearVista Clinical Research, LLC (01096)

    Bayonet Point, Florida, 34667

    Recruiting

  • Charleston Neuroscience Institute (01037)

    Beaufort, South Carolina, 29902

    Recruiting

  • Retina Consultants of Texas - Bellaire (01067)

    Bellaire, Texas, 77401

    Recruiting

  • Envision Ocular, LLC (01027)

    Bloomfield, New Jersey, 07003

    Recruiting

  • Advance Retina Institute

    Bonita Springs, Florida, 34134

    Recruiting

  • Retinal Diagnostic Center

    Campbell, California, 95008

    Recruiting

  • Midwest Eye Institute (01066)

    Carmel, Indiana, 46032

    Recruiting

  • Mid Atlantic Retina (01039)

    Cherry Hill, New Jersey, 08034

    Recruiting

  • The Retina Group of Washington (01089)

    Chevy Chase, Maryland, 29902

    Recruiting

  • Retina Assocaites of Cleveland, Inc (01048)

    Cleveland, Ohio, 44122

    Recruiting

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44130

    Recruiting

  • Texas Retina Associates

    Dallas, Texas, 75231

    Recruiting

  • Connecticut Eye Consultants, PC (01074)

    Danbury, Connecticut, 06810

    Recruiting

  • NJ Retina (01031)

    Edison, New Jersey, 08820

    Recruiting

  • The Retina Partners - Encino

    Encino, California, 07003

    Recruiting

  • Verum Research, LLC

    Eugene, Oregon, 97401

    Recruiting

  • Retina Consultants of Orange County - Fullerton Office

    Fullerton, California, 93825

    Recruiting

  • Associated Retina Consultants (01065)

    Gilbert, Arizona, 85297

    Recruiting

  • Long Island Vitreoretinal Consultants (01050)

    Great Neck, New York, 11021

    Recruiting

  • Retina Consultants of Carolina, PA (01073)

    Greenville, South Carolina, 29605

    Recruiting

  • Cumberland Valley Retina Consultants (CVRC)

    Hagerstown, Maryland, 21740

    Recruiting

  • Salehi Retina Institute, Inc dba Retina Associate or Southern California (01034)

    Huntington Beach, California, 92647

    Recruiting

  • Salehi Retina Institute, Inc. Dba Retina Associates of Southern California (01034)

    Huntington Beach, California, 92647

    Recruiting

  • Vision Research Solutions

    Indianapolis, Indiana, 21044

    Recruiting

  • Advancing Research International. LLC (01090)

    Indianapolis, Indiana, 46214

    Recruiting

  • Retina Consultants P.C.

    Indianapolis, Indiana, 46214

    Recruiting

  • Retina Consultants of Texas - Katy

    Katy, Texas, 77494

    Recruiting

  • Eye Care Specialists

    Kingston, Pennsylvania, 18704

    Recruiting

  • Charleston Neuroscience Institute LLC - Ladson

    Ladson, South Carolina, 29456

    Recruiting

  • Colorado Retina Associates, PLLC

    Lakewood, Colorado, 80228

    Recruiting

  • Long Island Vitreoretinal Consultants - Westbury

    Long Island City, New York, 11590

    Recruiting

  • Advanced Vision Research Institute

    Longmont, Colorado, 80503

    Recruiting

  • Piedmont Eye Center (01097)

    Lynchburg, Virginia, 24502

    Recruiting

  • Mississippi Retina Associates

    Madison, Mississippi, 39110

    Recruiting

  • University of Wisconsin Health - University Station Clinic

    Madison, Wisconsin, 53705

    Recruiting

  • Valley Retina Institute- McAllen (01076)

    McAllen, Texas, 78503

    Recruiting

  • Barnet Dulaney Perkins Eye Center (01018)

    Mesa, Arizona, 85206

    Recruiting

  • Retina Associates New Orleans - Jefferson Parish Location

    Metairie, Louisiana, 70001

    Recruiting

  • Charleston Neuroscience Institute, LLC - Mount Pleasant (01051)

    Mt. Pleasant, South Carolina, 29464

    Recruiting

  • Tennessee Retina, PC (01063)

    Nashville, Tennessee, 37203

    Recruiting

  • Illinois Retina Associates, S.C. - Oak Park (01061)

    Oak Park, Illinois, 60304

    Recruiting

  • Florida Retina Institute (01053)

    Orlando, Florida, 32806

    Recruiting

  • Florida Retina Institute - Orlando (01053)

    Orlando, Florida, 32806

    Recruiting

  • California Retina Consultants (01054)

    Oxnard, California, 93036

    Recruiting

  • Retina Specialty Institute - Pensacola

    Pensacola, Florida, 32503

    Recruiting

  • Mid Atlantic Retina - Philadelphia (01017)

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona, 85020

    Recruiting

  • Retinal Research Institute, LLC (01021)

    Phoenix, Arizona, 85053

    Recruiting

  • Eye Associates of Pinellas (01020)

    Pinellas Park, Florida, 33782

    Recruiting

  • EyeHealth Northwest

    Portland, Oregon, 97225

    Recruiting

  • EyeHealth Northwest (01006)

    Portland, Oregon, 97228

    Recruiting

  • Retina Consultants San Diego

    Poway, California, 92064

    Recruiting

  • Austin Retina Associates - Round Rock (01032)

    Round Rock, Texas, 78681

    Recruiting

  • Retina Associates of Utah (01052)

    Salt Lake City, Utah, 84107

    Recruiting

  • Retina Consultants of Texas - San Antonio Medical Center

    San Antonio, Texas, 78240

    Recruiting

  • Austin Retina Associate (01046)

    San Marcos, Texas, 78666

    Recruiting

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

    Recruiting

  • Retina Consultants of Texas (01055)

    Schertz, Texas, 78154

    Recruiting

  • Research Network Arizona

    Scottsdale, Arizona, 46214

    Recruiting

  • Ophthalmology Ltd. (01084)

    Sioux Falls, South Dakota, 57108

    Recruiting

  • Retina Center of Texas - Southlake

    Southlake, Texas, 76092

    Recruiting

  • Cascade Medical Research Institute, LLC (01070)

    Springfield, Oregon, 97477

    Recruiting

  • Retina Vitreous Associates of Florida (RVA) - Saint Petersburg

    St. Petersburg, Florida, 33711

    Recruiting

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

    Recruiting

  • Retina Consultants of Texas - The Woodlands

    The Woodlands, Texas, 73384

    Recruiting

  • NJ Retina (01030)

    Toms River, New Jersey, 08755

    Recruiting

  • Retina Macula Institute

    Torrance, California, 90503

    Recruiting

  • Retina Specialists

    Towson, Maryland, 21204

    Recruiting

  • Tyler Retina Consultants

    Tyler, Texas, 75703

    Recruiting

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California, 94598

    Recruiting

  • Salt Lake Retina (01044)

    West Jordan, Utah, 84088

    Recruiting

  • Center for Retina and Macular Disease (01026)

    Winter Haven, Florida, 33880

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneration

A Phase 2, Randomized, Placebo-controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 in Combination with Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Being tested
APL-3007, pegcetacoplan (APL-2), Placebo, Syfovre

What participants receive

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

  • APL-3007, pegcetacoplan (APL-2)Drug

    Complement C3 inhibitor

  • APL-3007, pegcetacoplan (APL-2)Drug

    Complement C3 Inhibitor

  • Placebo, SyfovreOther

    Complement C3 Inhibitor

Study groups in NCT07215390
Study groupRoleWhat they receive
Group 1 (APL-3007 Dose/Frequency 1 )ExperimentalAPL-3007 SC + pegcetacoplan (APL-2)
Receives: Drug: APL-3007, pegcetacoplan (APL-2)
Group 2 (APL-3007 Dose/Frequency 2)ExperimentalAPL-3007 + pegcetacoplan (APL-2)
Receives: Drug: APL-3007, pegcetacoplan (APL-2)
Group 3 (placebo)Placebo comparatorPlacebo SC + pegcetacoplan (APL-2)
Receives: Other: Placebo, Syfovre

What is being measured

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

  1. Change from baseline (CFB) in the area of artificial intelligence (AI)-based SD-OCT assessment of RPE lesion in the study eye

    Measured: At month 12

Secondary outcomes (9)

  1. CFB in the area of AI-based OCT assessment of photoreceptor degeneration in the study eye

    Measured: At month 12

  2. Safety & tolerability based on adverse event (AE) reporting

    Measured: At month 12

  3. Safety as assessed by Best Corrected Visual Acuity (BCVA)

    Continuous monitoring of a subject' BCVA as assessed by EDTRS chart

    Measured: At Month 12

  4. Change from baseline in Serum C3 level

    Continuous monitoring of a subject's Serum C3 level

    Measured: At Month 12

  5. CFB in RPE lesion area as assessed by FAF in the study eye

    Measured: At month 12

  6. CFB in the junctional zone, central 2o and 6o MP number of scotomatous points in the study eye

    Measured: At month 12

  7. CFB in the junctional zone, central 2o and 6o MP mean sensitivities in the study eye

    Measured: At month 12

  8. CFB in normal luminance qCSF in the study eye as assessed with the Adaptive Sensory Technology Manifold Platform

    Measured: At month 12

  9. CFB in low luminance qCSF in the study eye as assessed with the Adaptive Sensory Technology Manifold platform

    Measured: At month 12

Timeline

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

  1. First posted10 Oct 2025
  2. Study start23 Jun 2025
  3. Primary completion25 Jun 2027 (estimated)
  4. Study completionNov 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
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215390
Sponsor's protocol ID
APL3007-GA-201
Status last verified
Jun 2026
First submitted
30 Jun 2025
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APL-3007, pegcetacoplan (APL-2) in people with Geographic Atrophy Secondary to Age-related Macular Degeneration, run by Apellis Pharmaceuticals, Inc. at 78 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 22 inclusion and 39 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: looking for participants now, as of the sponsor's last update on 24 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 78 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Apellis Clinical Trial Information Line (617-977-5700, clinicaltrials@apellis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline (CFB) in the area of artificial intelligence (AI)-based SD-OCT assessment of RPE lesion in the study eye (time frame: At month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215390.

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 24 Jun 2026.

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