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.
RO7200220 is a recombinant fully humanized immunoglobulin G2 (IgG2) isotype monoclonal antibody (mAb) that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 signaling.
At the recent SEC meeting for Ophthalmology held on 21st June 2023, the expert panel reviewed the proposal presented by Roche for the grant of permission to conduct Phase III clinical trial protocol no GR44278, version 1.0 dated 30 Aug 2022.
After detailed deliberation, the committee recommended to revise the study protocol as follows:
1. SoC should be provided in Arm C (Sham Arm) since the subject with uveitic macular edema should not be left untreated.
2. Under Inclusion criteria, patients with uveitic macular edema who are non-responders to corticosteroids or have corticosteroids related complications should only be included in the trial.
In view of the above, the expert panel suggested that the firm should submit the revised protocol for further deliberation by the committee.
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