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MAGIC: Study Design and Rationale for the Phase 2 Clinical Trial of Faricimab for Non-Proliferative Diabetic Retinopathy
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DOI：10.1159/000550491.png)
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Abstract
En 中文
Purpose: Describe the design and rationale of the MAGIC (ClinicalTrials.gov identifier, NCT05681884) trial assessing change in retinal nonperfusion (RNP) among eyes with non-proliferative diabetic retinopathy (NPDR) in sham and treated patients. Design: Phase 2 prospective, randomized, multicenter, open-label, clinical trial. Participants: Adults with NPDR and substantial RNP (>5 disc areas) on ultra-widefield fluorescein angiography images. Methods: Patients will be randomized (1:1) into 1 of 2 arms: group 1 receiving intravitreal faricimab 6 mg every 4 weeks (Q4W) and group 2 being observed Q16W. At 48 weeks, group 1 will receive faricimab Q16W and group 2 will initiate faricimab Q4W through the final trial endpoint at year 2. The primary endpoint is change in RNP area through week 48. Secondary endpoints include change in RNP area through week 96; percentage of neovascularization, vitreous hemorrhage, DME, and/or PDR development; change in best-corrected visual acuity; change in central subfield thickness; contrast sensitivity (CS) measured using the quantitative contrast sensitivity function (qCSF); detection of apoptosing retinal cells (DARC) analysis; and proportion of subjects with >= 2-step improvement in Diabetic Retinopathy Severity Score (DRSS). Safety outcomes include incidence and severity of adverse events. Main Outcome Measures: Study design rationale. Results: Recruitment commenced in May 2023 and was completed in May 2024. Group 1 will be dosed Q4W to maximize detection of an impact on RNP progression compared to the untreated group 2. During year 2, group 1 will be dosed Q16W to assess for maintenance of any changes in RNP trajectory achieved during year 1. Group 2 will assess the natural history of RNP progression through year 1, then transition to maximal dosing to evaluate for a potential change in trajectory of RNP progression. Additional assessments, including CS and DARC, will address the unmet need for a better understanding of visual dysfunction among patients with NPDR and investigate the potential role of apoptosis in RNP, respectively. Conclusion: MAGIC is a randomized clinical trial that assesses RNP progression among eyes with NPDR, including its natural history and the impact of faricimab. Its innovative study design also explores the utility of novel assessments of retinal physiology and function.
Keywords:
Retinal nonperfusion
Study design
Faricimab
Non-proliferative diabetic retinopathy
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