Clinical trial to Compare the Efficacy, Safety, and Immunogenicity of Lupinâ??s Aflibercept with Eylea® in Patients with Neovascular Age-Related Macular Degeneration

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Lupinâ??s Aflibercept: Lupinâ??s Aflibercept will be administered at a dose of 2 mg every 4 weeks for initial 12 weeks and thereafter every 8 weeks (last dose at Week 40) as intravitreal injection (study duration will be approximately 52 weeks for each patient which will include: Screening Period up to 28 days and Treatment Period of 48 weeks Control Intervention1: Eylea: Eylea will be administered at a dose of 2 mg every 4 weeks for initial 12 weeks and thereafter every 8 weeks (last dose at Week 40) as intravitreal injection (study duration will be approximately 52 weeks for each patient which will include: Screening Period up to 28 days and Treatment Period of 48 weeks) CONDITION: Health Condition 1: H353‐ Degeneration of macula and posterior pole PRIMARY OUTCOME: Mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 48.Timepoint: From baseline to Week 48. SECONDARY OUTCOME: Efficacy Endpoint: Mean change in BCVA from baseline to Week 16 and Week 32.Timepoint: From baseline to Week 16 and Week 32. Immunogenicity Endpoint: Proportion of patients with anti‐drug antibodies at pre‐dose (Day 1), 4, 8, 16, 32, and 48 weeks.Timepoint: At pre‐dose (Day 1), 4, 8, 16, 32, and 48 weeks. Safety Endpoint: Incidence of treatment emergent adverse events (TEAEs). ; Timepoint: Screening visit to End of study visit. INCLUSION CRITERIA: 1.Ambulatory male or female participants with age >=50 years who are capable of understanding and giving written informed consent. 2.Active sub‐foveal choroidal neovascularization (CNV) lesion secondary to AMD in the study eye. Active CNV is defined as any leakage detected on fluorescein angiography (FA). 3.BCVA between 20/40 and 20/200 (Snellen equivalent), both inclusive, in the study eye before pupil dilation, using Early treatment diabetic retinopathy study (ETDRS) testing. 4.Females, who are of non‐childbearing potential (surgically sterile or menopausal), OR, if of childbearing potential using effective birth control measures during the study and 3 months after the last dose and who are non‐pregnant and non‐lactating at study entry. 5.Willing and able to undertake all scheduled visits and assessments.
Epistemonikos ID: 75d0460a8b3f82277947198d281ade7d941a5bad
First added on: Feb 20, 2024