Geographic Atrophy Clinical Trials

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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 Degeneration

Status: Recruiting
Location: See all (78) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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.

• 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

Locations
United States
Arizona
Associated Retina Consultants (01065)
RECRUITING
Gilbert
Barnet Dulaney Perkins Eye Center (01018)
RECRUITING
Mesa
Associated Retina Consultants - Phoenix
RECRUITING
Phoenix
Retinal Research Institute, LLC (01021)
RECRUITING
Phoenix
Research Network Arizona
RECRUITING
Scottsdale
California
California Retina Consultants (CRC) - Bakersfield Office
RECRUITING
Bakersfield
Retinal Diagnostic Center
RECRUITING
Campbell
The Retina Partners - Encino
RECRUITING
Encino
Retina Consultants of Orange County - Fullerton Office
RECRUITING
Fullerton
Salehi Retina Institute, Inc dba Retina Associate or Southern California (01034)
RECRUITING
Huntington Beach
Salehi Retina Institute, Inc. Dba Retina Associates of Southern California (01034)
RECRUITING
Huntington Beach
California Retina Consultants (01054)
RECRUITING
Oxnard
Retina Consultants San Diego
RECRUITING
Poway
Orange County Retina Medical Group
RECRUITING
Santa Ana
Retina Macula Institute
RECRUITING
Torrance
Bay Area Retina Associates - Walnut Creek
RECRUITING
Walnut Creek
Colorado
Colorado Retina Associates, PLLC
RECRUITING
Lakewood
Advanced Vision Research Institute
RECRUITING
Longmont
Connecticut
Connecticut Eye Consultants, PC (01074)
RECRUITING
Danbury
Florida
ClearVista Clinical Research, LLC (01096)
RECRUITING
Bayonet Point
Advance Retina Institute
RECRUITING
Bonita Springs
Florida Retina Institute - Orlando (01053)
RECRUITING
Orlando
Florida Retina Institute (01053)
RECRUITING
Orlando
Retina Specialty Institute - Pensacola
RECRUITING
Pensacola
Eye Associates of Pinellas (01020)
RECRUITING
Pinellas Park
Retina Vitreous Associates of Florida (RVA) - Saint Petersburg
RECRUITING
St. Petersburg
Retina Vitreous Associates of Florida
RECRUITING
Tampa
Center for Retina and Macular Disease (01026)
RECRUITING
Winter Haven
Georgia
Southeast Retina Center
RECRUITING
Augusta
Illinois
Illinois Retina Associates, S.C. - Oak Park (01061)
RECRUITING
Oak Park
Indiana
Midwest Eye Institute (01066)
RECRUITING
Carmel
Advancing Research International. LLC (01090)
RECRUITING
Indianapolis
Retina Consultants P.C.
RECRUITING
Indianapolis
Vision Research Solutions
RECRUITING
Indianapolis
Louisiana
Retina Associates New Orleans - Jefferson Parish Location
RECRUITING
Metairie
Maryland
The Retina Care Center
RECRUITING
Baltimore
The Retina Group of Washington (01089)
RECRUITING
Chevy Chase
Cumberland Valley Retina Consultants (CVRC)
RECRUITING
Hagerstown
Retina Specialists
RECRUITING
Towson
Mississippi
Mississippi Retina Associates
RECRUITING
Madison
New Jersey
Envision Ocular, LLC (01027)
RECRUITING
Bloomfield
Mid Atlantic Retina (01039)
RECRUITING
Cherry Hill
NJ Retina (01031)
RECRUITING
Edison
NJ Retina (01030)
RECRUITING
Toms River
New Mexico
Vision Research Center Eye Associates of New Mexico (01023)
RECRUITING
Albuquerque
New York
Long Island Vitreoretinal Consultants (01050)
RECRUITING
Great Neck
Long Island Vitreoretinal Consultants - Westbury
RECRUITING
Long Island City
Ohio
Retina Assocaites of Cleveland, Inc (01048)
RECRUITING
Cleveland
Retina Associates of Cleveland
RECRUITING
Cleveland
Oregon
Verum Research, LLC
RECRUITING
Eugene
EyeHealth Northwest
RECRUITING
Portland
EyeHealth Northwest (01006)
RECRUITING
Portland
Cascade Medical Research Institute, LLC (01070)
RECRUITING
Springfield
Pennsylvania
Eye Care Specialists
RECRUITING
Kingston
Mid Atlantic Retina - Philadelphia (01017)
RECRUITING
Philadelphia
South Carolina
Charleston Neuroscience Institute (01037)
RECRUITING
Beaufort
Retina Consultants of Carolina, PA (01073)
RECRUITING
Greenville
Charleston Neuroscience Institute LLC - Ladson
RECRUITING
Ladson
Charleston Neuroscience Institute, LLC - Mount Pleasant (01051)
RECRUITING
Mt. Pleasant
South Dakota
Ophthalmology Ltd. (01084)
RECRUITING
Sioux Falls
Tennessee
Tennessee Retina, PC (01063)
RECRUITING
Nashville
Texas
Retina Consultants of Texas - Abilene (01035)
RECRUITING
Abilene
Austin Retina Associates
RECRUITING
Austin
Retina Consultants of Texas - Bellaire (01067)
RECRUITING
Bellaire
Texas Retina Associates
RECRUITING
Dallas
Retina Consultants of Texas - Katy
RECRUITING
Katy
Valley Retina Institute- McAllen (01076)
RECRUITING
Mcallen
Austin Retina Associates - Round Rock (01032)
RECRUITING
Round Rock
Retina Consultants of Texas - San Antonio Medical Center
RECRUITING
San Antonio
Austin Retina Associate (01046)
RECRUITING
San Marcos
Retina Consultants of Texas (01055)
RECRUITING
Schertz
Retina Center of Texas - Southlake
RECRUITING
Southlake
Retina Consultants of Texas - The Woodlands
RECRUITING
The Woodlands
Tyler Retina Consultants
RECRUITING
Tyler
Utah
Retina Associates of Utah (01052)
RECRUITING
Salt Lake City
Salt Lake Retina (01044)
RECRUITING
West Jordan
Virginia
Piedmont Eye Center (01097)
RECRUITING
Lynchburg
Wisconsin
University of Wisconsin Health - University Station Clinic
RECRUITING
Madison
Contact Information
Primary
Apellis Clinical Trial Information Line
clinicaltrials@apellis.com
617-977-5700
Time Frame
Start Date: 2025-06-23
Estimated Completion Date: 2027-11
Participants
Target number of participants: 240
Treatments
Experimental: Group 1 (APL-3007 Dose/Frequency 1 )
APL-3007 SC + pegcetacoplan (APL-2)
Experimental: Group 2 (APL-3007 Dose/Frequency 2)
APL-3007 + pegcetacoplan (APL-2)
Placebo_comparator: Group 3 (placebo)
Placebo SC + pegcetacoplan (APL-2)
Sponsors
Leads: Apellis Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

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