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

At the recent SEC meeting for Ophthalmology held on 19th March 2025, the expert panel reviewed the proposal to conduct a Phase IV clinical trial to evaluate the safety and efficacy of Injection Ranibizumab (of sponsor Lupin Limited) given as an intravitreal injection in preterm infants with retinopathy of prematurity.

After detailed deliberation, the committee recommended to conduct the study with the following changes in the protocol:-

1. Proper, detailed study methodology should be provided and SOP should be a part of the study design.

2. Perkins tonometer should be used for measurement of IOP. If IOP is raised, then a small parenthesis should be performed.

3. Study should include pre-term infants with natural spontaneous breathing/normal breathing only.

4. Micro-ROPLAS test should be performed at screening to exclude congenital NLDO.

5. Echo test should be performed at screening if an abnormality in the ECG is suspected.

6. If both the eyes are eligible for the study treatment as per the inclusion criteria, treatment should be providedsimultaneously.

In line with the above, the expert panel suggested that the firm shall submit the revised protocol to CDSCO for further evaluation.

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