Actively Recruiting

Phase 2
Age: 60Years +
All Genders
NCT07215390

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

Led by Apellis Pharmaceuticals, Inc. · Updated on 2026-03-30

240

Participants Needed

43

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

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 Degeneratio

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Study eye must meet all inclusion criteria; if both eyes qualify, the eye with better visual acuity at screening will be the study eye
  • Aged 60 years or older
  • Clinical diagnosis of geographic atrophy secondary to age-related macular degeneration in one or both eyes confirmed by reading center
  • Normal luminance best corrected visual acuity (NL-BCVA) of 50 letters or better on ETDRS charts
  • Adequate ocular media clarity, pupillary dilation, and fixation for quality imaging
  • Prior Syfovre treatment in the study eye at 6-8 week intervals for at least 6 months but no more than 24 months, with at least 2 injections in the last 6 months
  • GA lesion in study eye with total area between 2.5 and 17.5 mm2, with specific lesion size and location criteria confirmed by central reading center
  • Presence of any hyperautofluorescence pattern in the junctional zone of GA on FAF imaging
  • Documented vaccination within 5 years or willingness to initiate vaccinations at least 14 days prior to dosing against specified bacteria
  • Women must be non-childbearing or use contraception with negative pregnancy test; men must be surgically sterile or use contraception
  • Willing and able to provide informed consent and adhere to study schedule
Not Eligible

You will not qualify if you...

  • Uncontrolled or clinically relevant history of major systemic diseases or cancer
  • History or presence of liver disease increasing risk of drug-induced liver injury
  • History or presence of systemic autoimmune disorders except well-controlled Hashimoto's thyroiditis
  • Allergy or serious reaction to siRNA therapy or study drug components
  • Clinically meaningful cardiac, hepatic, or renal abnormalities on diagnostic testing
  • History or presence of malignancy except skin basal or squamous cell carcinoma treated over 1 year ago
  • History or presence of recurrent infections or certain viral infections including HIV, hepatitis B and C
  • Fever or acute infection including COVID-19 within 30 days before dosing
  • Evidence of drug or alcohol abuse
  • Intention to donate sperm during study or within 90 days after last dose
  • Prior administration of APL-3007
  • Participation in other investigational product or device study within 5 half-lives before screening
  • Poor peripheral venous access or skin conditions interfering with injections
  • Any condition or treatment interfering with study conduct or increasing risk
  • Live vaccination within 30 days before first dose except seasonal flu
  • Pregnancy or breastfeeding
  • Medical or psychiatric conditions limiting study compliance or safety
  • Ocular exclusions specific to study eye including GA from other causes, history of CNV or neovascularization, active ocular diseases impairing vision, recent IVT injections except Syfovre, prior investigational GA treatments within 3 months, laser therapy in macula, or ocular conditions requiring surgery or intervention during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 43 locations

1

Barnet Dulaney Perkins Eye Center (01018)

Mesa, Arizona, United States, 85206

Actively Recruiting

2

Associated Retina Consultants - Phoenix

Phoenix, Arizona, United States, 85020

Actively Recruiting

3

Retinal Research Institute, LLC (01021)

Phoenix, Arizona, United States, 85053

Actively Recruiting

4

California Retina Consultants (CRC) - Bakersfield Office

Bakersfield, California, United States, 93309

Actively Recruiting

5

The Retina Partners - Encino

Encino, California, United States, 07003

Actively Recruiting

6

Retina Consultants of Orange County - Fullerton Office

Fullerton, California, United States, 93825

Actively Recruiting

7

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

Huntington Beach, California, United States, 92647

Actively Recruiting

8

Retina Consultants San Diego

Poway, California, United States, 92064

Actively Recruiting

9

Orange County Retina Medical Group

Santa Ana, California, United States, 92705

Actively Recruiting

10

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, United States, 94598

Actively Recruiting

11

Colorado Retina Associates, PLLC

Lakewood, Colorado, United States, 80228

Actively Recruiting

12

Advanced Vision Research Institute

Longmont, Colorado, United States, 80503

Actively Recruiting

13

Florida Retina Institute - Orlando (01053)

Orlando, Florida, United States, 32806

Actively Recruiting

14

Retina Specialty Institute - Pensacola

Pensacola, Florida, United States, 32503

Actively Recruiting

15

Retina Vitreous Associates of Florida (RVA) - Saint Petersburg

St. Petersburg, Florida, United States, 33711

Actively Recruiting

16

Center for Retina and Macular Disease (01026)

Winter Haven, Florida, United States, 33880

Actively Recruiting

17

Southeast Retina Center

Augusta, Georgia, United States, 30909

Actively Recruiting

18

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

Oak Park, Illinois, United States, 60304

Actively Recruiting

19

Retina Consultants P.C.

Indianapolis, Indiana, United States, 46214

Actively Recruiting

20

Retina Associates New Orleans - Jefferson Parish Location

Metairie, Louisiana, United States, 70001

Actively Recruiting

21

Cumberland Valley Retina Consultants (CVRC)

Hagerstown, Maryland, United States, 21740

Actively Recruiting

22

Mississippi Retina Associates

Madison, Mississippi, United States, 39110

Actively Recruiting

23

Long Island Vitreoretinal Consultants - Westbury

Long Island City, New York, United States, 11590

Actively Recruiting

24

Retina Assocaites of Cleveland, Inc (01048)

Cleveland, Ohio, United States, 44122

Actively Recruiting

25

Verum Research, LLC

Eugene, Oregon, United States, 97401

Actively Recruiting

26

EyeHealth Northwest

Portland, Oregon, United States, 97225

Actively Recruiting

27

Mid Atlantic Retina - Philadelphia (01017)

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

28

Charleston Neuroscience Institute LLC - Ladson

Ladson, South Carolina, United States, 29456

Actively Recruiting

29

Charleston Neuroscience Institute, LLC - Mount Pleasant (01051)

Mt. Pleasant, South Carolina, United States, 29464

Actively Recruiting

30

Retina Consultants of Texas - Abilene (01035)

Abilene, Texas, United States, 79606

Actively Recruiting

31

Austin Retina Associates

Austin, Texas, United States, 78705

Actively Recruiting

32

Retina Consultants of Texas - Bellaire (01067)

Bellaire, Texas, United States, 77401

Actively Recruiting

33

Texas Retina Associates

Dallas, Texas, United States, 75231

Actively Recruiting

34

Retina Consultants of Texas - Katy

Katy, Texas, United States, 77494

Actively Recruiting

35

Valley Retina Institute- McAllen (01076)

McAllen, Texas, United States, 78503

Actively Recruiting

36

Austin Retina Associates - Round Rock (01032)

Round Rock, Texas, United States, 78681

Actively Recruiting

37

Retina Consultants of Texas - San Antonio Medical Center

San Antonio, Texas, United States, 78240

Actively Recruiting

38

Austin Retina Associate (01046)

San Marcos, Texas, United States, 78666

Actively Recruiting

39

Retina Consultants of Texas (01055)

Schertz, Texas, United States, 78154

Actively Recruiting

40

Retina Center of Texas - Southlake

Southlake, Texas, United States, 76092

Actively Recruiting

41

Retina Consultants of Texas - The Woodlands

The Woodlands, Texas, United States, 73384

Actively Recruiting

42

Tyler Retina Consultants

Tyler, Texas, United States, 75703

Actively Recruiting

43

University of Wisconsin Health - University Station Clinic

Madison, Wisconsin, United States, 53705

Actively Recruiting

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Research Team

A

Apellis Clinical Trial Information Line

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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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 | DecenTrialz