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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT07215390
Phase
PHASE2
Status
Recruiting

Conditions

  • Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jun 23, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

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 ]

Central Contacts

Locations (68)

FacilityCityStateZIPSite coordinators
Associated Retina Consultants (01065)GilbertArizona85297-
Barnet Dulaney Perkins Eye Center (01018)MesaArizona85206-
Associated Retina Consultants - PhoenixPhoenixArizona85020-
Retinal Research Institute, LLC (01021)PhoenixArizona85053-
California Retina Consultants (CRC) - Bakersfield OfficeBakersfieldCalifornia93309-
The Retina Partners - EncinoEncinoCalifornia07003-
Retina Consultants of Orange County - Fullerton OfficeFullertonCalifornia93825-
Salehi Retina Institute, Inc dba Retina Associate or Southern California (01034)Huntington BeachCalifornia92647-
Salehi Retina Institute, Inc. Dba Retina Associates of Southern California (01034)Huntington BeachCalifornia92647-
California Retina Consultants (01054)OxnardCalifornia93036-
Retina Consultants San DiegoPowayCalifornia92064-
Orange County Retina Medical GroupSanta AnaCalifornia92705-
Bay Area Retina Associates - Walnut CreekWalnut CreekCalifornia94598-
Colorado Retina Associates, PLLCLakewoodColorado80228-
Advanced Vision Research InstituteLongmontColorado80503-
Connecticut Eye Consultants, PC (01074)DanburyConnecticut06810-
ClearVista Clinical Research, LLC (01096)Bayonet PointFlorida34667-
Florida Retina Institute - Orlando (01053)OrlandoFlorida32806-
Florida Retina Institute (01053)OrlandoFlorida32806-
Retina Specialty Institute - PensacolaPensacolaFlorida32503-
Eye Associates of Pinellas (01020)Pinellas ParkFlorida33782-
Retina Vitreous Associates of Florida (RVA) - Saint PetersburgSt. PetersburgFlorida33711-
Center for Retina and Macular Disease (01026)Winter HavenFlorida33880-
Southeast Retina CenterAugustaGeorgia30909-
Illinois Retina Associates, S.C. - Oak Park (01061)Oak ParkIllinois60304-
Midwest Eye Institute (01066)CarmelIndiana46032-
Advancing Research International. LLC (01090)IndianapolisIndiana46214-
Retina Consultants P.C.IndianapolisIndiana46214-
Retina Associates New Orleans - Jefferson Parish LocationMetairieLouisiana70001-
The Retina Group of Washington (01089)Chevy ChaseMaryland29902-
Cumberland Valley Retina Consultants (CVRC)HagerstownMaryland21740-
Mississippi Retina AssociatesMadisonMississippi39110-
Envision Ocular, LLC (01027)BloomfieldNew Jersey07003-
Mid Atlantic Retina (01039)Cherry HillNew Jersey08034-
NJ Retina (01031)EdisonNew Jersey08820-
NJ Retina (01030)Toms RiverNew Jersey08755-
Vision Research Center Eye Associates of New Mexico (01023)AlbuquerqueNew Mexico87109-
Long Island Vitreoretinal Consultants (01050)Great NeckNew York11021-
Long Island Vitreoretinal Consultants - WestburyLong Island CityNew York11590-
Retina Assocaites of Cleveland, Inc (01048)ClevelandOhio44122-
Verum Research, LLCEugeneOregon97401-
EyeHealth NorthwestPortlandOregon97225-
EyeHealth Northwest (01006)PortlandOregon97228-
Cascade Medical Research Institute, LLC (01070)SpringfieldOregon97477-
Mid Atlantic Retina - Philadelphia (01017)PhiladelphiaPennsylvania19107-
Charleston Neuroscience Institute (01037)BeaufortSouth Carolina29902-
Retina Consultants of Carolina, PA (01073)GreenvilleSouth Carolina29605-
Charleston Neuroscience Institute LLC - LadsonLadsonSouth Carolina29456-
Charleston Neuroscience Institute, LLC - Mount Pleasant (01051)Mt. PleasantSouth Carolina29464-
Ophthalmology Ltd. (01084)Sioux FallsSouth Dakota57108-
Tennessee Retina, PC (01063)NashvilleTennessee37203-
Retina Consultants of Texas - Abilene (01035)AbileneTexas79606-
Austin Retina AssociatesAustinTexas78705-
Retina Consultants of Texas - Bellaire (01067)BellaireTexas77401-
Texas Retina AssociatesDallasTexas75231-
Retina Consultants of Texas - KatyKatyTexas77494-
Valley Retina Institute- McAllen (01076)McAllenTexas78503-
Austin Retina Associates - Round Rock (01032)Round RockTexas78681-
Retina Consultants of Texas - San Antonio Medical CenterSan AntonioTexas78240-
Austin Retina Associate (01046)San MarcosTexas78666-
Retina Consultants of Texas (01055)SchertzTexas78154-
Retina Center of Texas - SouthlakeSouthlakeTexas76092-
Retina Consultants of Texas - The WoodlandsThe WoodlandsTexas73384-
Tyler Retina ConsultantsTylerTexas75703-
Retina Associates of Utah (01052)Salt Lake CityUtah84107-
Salt Lake Retina (01044)West JordanUtah84088-
Piedmont Eye Center (01097)LynchburgVirginia24502-
University of Wisconsin Health - University Station ClinicMadisonWisconsin53705-

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