Revise CT Protocol: CDSCO Panel Tells Roche on Ophthalmic Drug RO7200220
New Delhi: Responding to the drug major Roche's proposal to conduct a Phase III clinical trial of RO7200220, anti-interleukin-6 (IL-6), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to revise the study protocol in accordance with Standard of care (SoC) and Inclusion criteria of patients in the study.
This came after the firm presented the proposal for the grant of permission to conduct Phase III Clinical Trial Protocol No. GR44278, Version 1.0 dated 30 Aug 2022 before the committee.
In accordance with the Clinical Trial Protocol, this study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.
Uveitic macular edema is a complication of acute or chronic uveitis, characterized by the accumulation of fluid in the retinal layers or the subretinal space. It is the leading cause of visual impairment in cases with uveitis. IL-6 is produced by multiple cells of the innate immune system and leads to a higher likelihood of developing autoimmune inflammatory diseases, such as non-infectious uveitis, through a variety of mechanisms.
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