Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
NCT Number: NCT05972473
The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
This study is active but is not currently recruiting participants.
Notify Me50 year and older
All sexes
Interventional
Phase 3
Shanghai, Shanghai Municipality, 200080, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).
8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.
Time frame: At week 44, 48, 52
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.
Time frame: At week 16
The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)
Time frame: Upto Week 100
Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: Upto Week 100
Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.
Time frame: Upto Week 100
the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA
Time frame: Upto Week 100
Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.
Time frame: Upto Week 100
All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) 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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