Innovent Biologics (Suzhou) Co,Ltd.
Suzhou, Jiangsu, 215123, China
NCT Number: NCT04820452
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.
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Notify Me50 year and older
All sexes
Interventional
Phase 2
Suzhou, Jiangsu, 215123, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection
High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
Intraocular injection
Time frame: Baseline to week 36
Time frame: Baseline to week 52
the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.
Time frame: Baseline to week 52
the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52
Time frame: Baseline to week 52
the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52
Time frame: Baseline to week 52
the incidence of ocular AE or any systemic AE, TEAE, SAE
Time frame: Baseline to week 52
the positive rate of anti-drug antibody and neutralizing antibody
Innovent Biologics (Suzhou) Co. Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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