A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

Part of paid clinical trials in Long Beach, California.

Sponsor
Amgen
Study ID
NCT07614776
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Neovascular Age-related Macular Degeneration
  • nAMD

Eligibility Criteria

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

Interventions

Study Details

The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)

Key Dates

Start date
May 27, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jan 12, 2028

Study Design

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

Arms

  • Experimental: ABP 938 8 mg
    Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
  • Active Comparator: Aflibercept (US) 8 mg
    Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria. Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.

Primary Outcome Measure

Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [ Time Frame: Baseline and Week 12 ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
South Coast Retina Center - RCALong BeachCalifornia90607-
California Eye Specialists Medical Group, IncPasadenaCalifornia91107-
Retina Consultants of San DiegoPowayCalifornia92064-
Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)SacramentoCalifornia95825-
Retina Group of FloridaFort LauderdaleFlorida33308-
Medeye Associates - ResearchMiamiFlorida33143-
Advanced Research, LLCPensacolaFlorida32503-
Retina AssociatesElmhurstIllinois60126-
Retina Consultants of MinnesotaEdinaMinnesota55435-
Mississippi Retina AssocMadisonMississippi39110-
Charleston Neuroscience InstituteCharlestonSouth Carolina29414-5896-
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)LadsonSouth Carolina29456-
Palmetto Retina Center, Florence (RCA)West ColumbiaSouth Carolina29169-
Texas Retina Associates (TRA) - ArlingtonArlingtonTexas76012-
Texas Retina Associates (TRA) - Dallas MainDallasTexas75231-
Texas Retina Associates - Fort WorthFort WorthTexas76104-
Retina Consultants of Texas - SchertzSchertzTexas78154-
Vitreoretinal Associates of WashingtonBellevueWashington98004-3779-

Find similar trials in Long Beach, CA

By research site
South Coast Retina Center - RCA· Long Beach, CACalifornia Eye Specialists Medical Group, Inc· Pasadena, CARetina Consultants of San Diego· Poway, CARetinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)· Sacramento, CARetina Group of Florida· Fort Lauderdale, FLMedeye Associates - Research· Miami, FL

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