Revise study protocol: CDSCO Panels tells Lupin on Ranibizumab Solution for Injection 10 mg/mL

New Delhi: Responding to the drug major Lupin's proposal to conduct phase IV clinical trial of the ophthalmic drug Ranibizumab Solution for Injection 10 mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that to revise the study protocol.

This came after the firm presented the proposal to conduct a Phase IV clinical trial titled “A multicenter, open-label, prospective, single-arm, non-comparative, non-randomized phase IV study to evaluate safety and efficacy of Injection Ranibizumab (of Sponsor Lupin Limited) given as an intravitreal injection in preterm infants with Retinopathy of Prematurity” vide Protocol No. 24-VIN-0299; Version No. 01; Dated: 05th September, 2024 with the few changes in the protocol.

Ranibizumab is a medication used to treat various eye conditions, primarily those involving abnormal blood vessel growth, such as wet age-related macular degeneration (AMD) and diabetic macular edema. It is a recombinant humanized monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A), a protein that stimulates new blood vessel formation.

It is a recombinant humanized monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A), a protein that stimulates new blood vessel formation