A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Rophibio, Inc.
Study ID
NCT06470373
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Neovascular Age-related Macular Degeneration (nAMD)

Eligibility Criteria

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

Interventions

  • RBS-001 Solution for intravitreal injection — DRUG
    Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye
  • Eylea® Solution for intravitreal injection — DRUG
    Administer 2 mg/eye (50 uL/eye) per dose of the IP via IVT to the subjects' study eye

Study Details

This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related macular degeneration.

Key Dates

Start date
Jul 31, 2025
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Active Comparator: RBS-001 treatment group
    All eligible subjects according to the inclusion/exclusion criteria will be randomized into the RBS-001 treatment group or Eylea® treatment group in a ratio of 1:1 with the BCVA score
  • Active Comparator: Eylea® treatment group
    All eligible subjects according to the inclusion/exclusion criteria will be randomized into the RBS-001 treatment group or Eylea® treatment group in a ratio of 1:1 with the BCVA score

Primary Outcome Measure

Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment [ Time Frame: The change from baseline (Day 1) to 8 weeks after the IP treatment ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Associated Retina Consultants - GilbertPhoenixArizona85297-
Associated Retina Consultants - PhoenixPhoenixArizona85021
Erin Fox
480-999-5458
Retina Partners of Northwest Arkansas, PLLCSpringdaleArkansas72764
Ethan Korpella
479-408-4470
Erie Retina ResearchEriePennsylvania16507
Bethany Scott
814-737-0203
Charles Retina InstituteGermantownTennessee38138
Molly Scott
901-767-4499
Retina Research Institute of TexasAbileneTexas79606
Deisy Villareal
325-690-4415
Strategic Clinical Research Group, LLCWillow ParkTexas76087
Ashley York
682-703-4318

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Associated Retina Consultants - Gilbert· Phoenix, AZAssociated Retina Consultants - Phoenix· Phoenix, AZRetina Partners of Northwest Arkansas, PLLC· Springdale, ARErie Retina Research· Erie, PACharles Retina Institute· Germantown, TNRetina Research Institute of Texas· Abilene, TX

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