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. 2023 Jun 14;2023(6):CD009300. doi: 10.1002/14651858.CD009300.pub3

NCT04820452.

Study name A study of IBI302 in patients with nAMD
Methods Phase 2, randomised, double‐blind, parallel group study at multiple centres, with active comparator
Participants Adults 50 years or older with active subfoveal or parafoveal CNV secondary to neovascular AMD in at least one eye and BCVA of 24 to 73 letters on the ETDRS chart. Participants with prior anti‐VEGF therapy within 3 months are excluded.
Interventions IBI302 administered intravitreally at 2 mg or 4 mg doses monthly for 3 months (loading phase) then every other month, compared to aflibercept 2 mg injection
Outcomes Primary outcome measures:
  • Change in BCVA scores in the study eye as assessed by the ETDRS chart (time frame: 36 weeks)


Secondary outcome measures:
  • Proportion of improvement in BCVA score ≥ 0, 5, 10, or 15 (time frame: 52 weeks)

  • Mean change in central subfield thickness from baseline (time frame: 52 weeks)

  • Change of CNV area, CNV leakage area, and total lesion area from baseline (time frame: 52 weeks)

  • Incidence of ocular or systemic adverse events (time frame: 52 weeks)

  • Rate of anti‐drug and neutralising antibodies (time frame: 52 weeks)

Starting date March 2021
Contact information Innovent Biologics (Suzhou) Co. Ltd.
Status Active, not recruiting
Required reporting date Unknown
Notes