A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05972473
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept Ophthalmic — DRUG
    2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).
  • IBI302 — BIOLOGICAL
    8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.

Study Details

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Key Dates

Start date
Sep 21, 2023
Status verified
Mar 2025
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
600 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Aflibercept
    Drug: Aflibercept 2mg/eye; Intraocular injection
  • Experimental: IBI302 dose 8mg
    Drug: IBI302 8mg/eye; Intraocular injection

Primary Outcome Measure

Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye. [ Time Frame: At week 44, 48, 52 ]

Related Studies