Efficacy and Safety of RC28-E Versus Aflibercept

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05727397
Phase
PHASE3
Status
Unknown

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • RC28-E — DRUG
    Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 µL dose.
  • Aflibercept — DRUG
    Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 µL dose.

Study Details

This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients with wet age-related macular degeneration.

Key Dates

Start date
Mar 14, 2023
Status verified
Feb 2023
Primary completion
Nov 29, 2025
Completion
Dec 29, 2025

Study Design

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

Arms

  • Experimental: RC28-E
    RC28-E 2 mg will be initially injected 3 times at 4 week intervals, then each subject will be injected every 12 weeks unless there is disease activity. If disease activity is identified, the subject will be reassigned to receive injections every 8 weeks thereafter, up to study exit.
  • Active Comparator: Aflibercept
    Aflibercept 2 mg will be injected 3 times at 4 week intervals, followed by injections every 8 weeks.

Primary Outcome Measure

Mean change from baseline in BCVA at week 48; [ Time Frame: Baseline, week 48 ]

Central Contacts

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