The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
After 4 loading monthly intravitreal injections of dose 1 IBI302,the following IBI302 IVT is given as descript in protocol.
Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month
After 4 loading monthly intravitreal injections of dose 2 IBI302,the following IBI302 IVT is given as descript in protocol
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Change of BCVA from baseline
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Time frame: Baseline to week 40
Percentage of Participants Loss >0,≥5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a loss in BCVA letter score from baseline indicates a decline in visual acuity.
Time frame: Baseline to week 52
Change of Central Subfield Thickness in the Study Eye from baseline
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane using optical coherence tomography (OCT), as assessed by the central reading center.
Time frame: Baseline to week 52
Change of Total Area of Choroidal Neovascularization (CNV) Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline
The total area of the choroidal neovascularization lesion/Total Area of Choroidal Neovascularization Leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Time frame: From Baseline to week 52
Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals
Time frame: At Week 20,40,52
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs of special interest. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity.
Time frame: From Baseline to week 52
Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Time frame: From Baseline to week 52
Immunogenicity end points
Production of anti-drug antibodies in serum.
Time frame: From Baseline to week 52