Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04370379
Phase
PHASE1
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • IBI302 (the first dose level) — DRUG
    q4week (3 injections) followed by PRN dosing
  • IBI302 (the second dose level) — DRUG
    q4week (3 injections) followed by PRN dosing
  • Aflibercept — DRUG
    2mg, q4week (3 injections) followed by q8week

Study Details

This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.

Key Dates

Start date
May 28, 2020
Status verified
Nov 2021
Primary completion
Apr 30, 2021
Completion
May 8, 2021

Study Design

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

Arms

  • Experimental: low dose of IBI302
  • Experimental: high dose of IBI302
  • Active Comparator: 2mg aflibercept

Primary Outcome Measure

Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography [ Time Frame: Baseline to Day140 ]

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