Find Age-Related Macular Degeneration (ARMD) Clinical Trials Near You
A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Men or women ≥ 50 years old, capable of giving signed informed consent
• Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
• Total area of CNV (including both classic and occult components) \> 50% of the total lesion area in the SE
• The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
• Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea
Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
RECRUITING
Ladson
Palmetto Retina Center, Florence (RCA)
RECRUITING
West Columbia
Texas
Texas Retina Associates (TRA) - Arlington
RECRUITING
Arlington
Texas Retina Associates (TRA) - Dallas Main
RECRUITING
Dallas
Texas Retina Associates - Fort Worth
RECRUITING
Fort Worth
Retina Consultants of Texas - Schertz
RECRUITING
Schertz
Washington
Vitreoretinal Associates of Washington
RECRUITING
Bellevue
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date:2026-05-27
Estimated Completion Date:2028-01-12
Participants
Target number of participants:304
Treatments
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.