A Study of IBI302 in Patients With nAMD
Phase 2
Completed
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT04820452
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cohort 1 IBI302 treated with high dose level of IBI302 High dose IBI302 Drug: IBI302 4mg/eye;Intraocular injection Aflibercept Aflibercept Drug: Aflibercept 2mg/eye;Intraocular injection cohort 1 IBI302 treated with low dose level of IBI302 Low dose IBI302 Drug: IBI302 2mg/eye;Intraocular injection
- Primary Outcome Measures
Name Time Method The visual efficacy of IBI302 Baseline to week 36
- Secondary Outcome Measures
Name Time Method the anatomical effects of IBI302 on FFA Baseline to week 52 the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52
the safety of IBI302 Baseline to week 52 the incidence of ocular AE or any systemic AE, TEAE, SAE
other visual effects of IBI302 Baseline to week 52 the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.
the anatomical effects of IBI302 on OCT Baseline to week 52 the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52
Immunogenicity of IBI302 Baseline to week 52 the positive rate of anti-drug antibody and neutralizing antibody
Trial Locations
- Locations (1)
Innovent Biologics (Suzhou) Co,Ltd.
🇨🇳Suzhou, Jiangsu, China