Evaluation of IBI302 Injection in nAMD or DME

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05961007
Phase
PHASE1/PHASE2
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Intravitreal injection of IBI302(dose 1) — BIOLOGICAL
    IBI302(dose 1) intravitreal injection given as protocol
  • Intravitreal injection of IBI302(dose 2) — BIOLOGICAL
    IBI302(dose 2) intravitreal injection given as protocol
  • Intravitreal injection of IBI302(dose 3) — BIOLOGICAL
    IBI302(dose 3) intravitreal injection given as protocol
  • Intravitreal injection of Aflibercept — DRUG
    Aflibercept intravitreal injection given as protocol

Study Details

The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.

Key Dates

Start date
Nov 18, 2021
Status verified
Jul 2023
Primary completion
Oct 31, 2023
Completion
Apr 30, 2024

Study Design

Enrollment
234 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Aflibercept
    only phase II
  • Experimental: IBI302

Primary Outcome Measure

Incidence and severity of ocular and non-ocular adverse events. [ Time Frame: Up to week 20 ]

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