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Clinical Trials/NCT04820452
NCT04820452
Completed
Phase 2

A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration

Innovent Biologics (Suzhou) Co. Ltd.1 site in 1 country231 target enrollmentApril 28, 2021
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ConditionsNeovascular Age-related Macular Degeneration
InterventionsHigh dose IBI302AfliberceptLow dose IBI302
DrugsLow dose IBI302High dose IBI302Aflibercept

Overview

Phase
Phase 2
Intervention
High dose IBI302
Conditions
Neovascular Age-related Macular Degeneration
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Enrollment
231
Locations
1
Primary Endpoint
The visual efficacy of IBI302
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 28, 2021
End Date
January 13, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

cohort 1 IBI302 treated with high dose level of IBI302

Drug: IBI302 4mg/eye;Intraocular injection

Intervention: High dose IBI302

Aflibercept

Drug: Aflibercept 2mg/eye;Intraocular injection

Intervention: Aflibercept

cohort 1 IBI302 treated with low dose level of IBI302

Drug: IBI302 2mg/eye;Intraocular injection

Intervention: Low dose IBI302

Outcomes

Primary Outcomes

The visual efficacy of IBI302

Time Frame: Baseline to week 36

Secondary Outcomes

  • the anatomical effects of IBI302 on FFA(Baseline to week 52)
  • the safety of IBI302(Baseline to week 52)
  • other visual effects of IBI302(Baseline to week 52)
  • the anatomical effects of IBI302 on OCT(Baseline to week 52)
  • Immunogenicity of IBI302(Baseline to week 52)

Study Sites (1)

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