Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05885503
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • RC-28E — BIOLOGICAL
    Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
  • Aflibercept — BIOLOGICAL
    Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.

Study Details

The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.

Key Dates

Start date
Jun 8, 2023
Status verified
May 2023
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: RC-28E
    RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48.
  • Active Comparator: Aflibercept
    Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48.

Primary Outcome Measure

Change from baseline in BCVA at Week 52 [ Time Frame: Baseline, week 52 ]

Central Contacts

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