A Study of IBI302 in Patients With nAMD

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04820452
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Low dose IBI302 — BIOLOGICAL
    Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection
  • High dose IBI302 — BIOLOGICAL
    High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
  • Aflibercept — DRUG
    Intraocular injection

Study Details

This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.

Key Dates

Start date
Apr 28, 2021
Status verified
Nov 2024
Primary completion
Jan 13, 2023
Completion
Jan 13, 2023

Study Design

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

Arms

  • Experimental: cohort 1 IBI302 treated with high dose level of IBI302
    Drug: IBI302 4mg/eye;Intraocular injection
  • Active Comparator: Aflibercept
    Drug: Aflibercept 2mg/eye;Intraocular injection
  • Experimental: cohort 1 IBI302 treated with low dose level of IBI302
    Drug: IBI302 2mg/eye;Intraocular injection

Primary Outcome Measure

The visual efficacy of IBI302 [ Time Frame: Baseline to week 36 ]

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