A Study of Longer Interval of IVT IBI302 in Subjects With nAMD

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05403749
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • dose 1 IBI302 — BIOLOGICAL
    After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol.
  • Aflibercept — DRUG
    Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month
  • dose 2 IBI302 — BIOLOGICAL
    After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol

Study Details

The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Key Dates

Start date
Jun 29, 2022
Status verified
Jun 2024
Primary completion
May 13, 2024
Completion
May 13, 2024

Study Design

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

Arms

  • Experimental: IBI302 dose 2 group
    Drug: Aflibercept 8mg/eye;Intraocular injection
  • Active Comparator: Aflibercept
    Drug: Aflibercept 2mg/eye;Intraocular injection
  • Experimental: IBI302 dose 1 group
    Drug: Aflibercept 6.4mg/eye;Intraocular injection

Primary Outcome Measure

Change of BCVA from baseline [ Time Frame: Baseline to week 40 ]

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