Tokyo, Jan. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060517) titled 'Efficacy of Brolucizumab for Proliferative Diabetic Retinopathy and Changes in Aqueous Humor Cytokine Levels: A Clinical Study' on Jan. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Gunma University

Condition: Condition - Proliferative Diabetic Retinopathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the efficacy and safety of brolucizumab in proliferative diabetic retinopathy. In addition, various clinical test results, imaging data, and aqueous humor cytokine profiles will be analyzed to investigate disease activity and factors associated with treatment discontinuation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intravitreal Brolucizumab

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients diagnosed with proliferative diabetic retinopathy

Patients aged 20 years or older

Treatment naive for PDR

Outpatients

Patients who have provided written informed consent to participate in this study

Patients who are not indicated for vitrectomy

Patients who have chosen brolucizumab treatment using the treat-and-extend regimen

Patients without diabetic macular edema Key exclusion criteria - History of active intraocular or periocular infections, or idiopathic/autoimmune uveitis

Patients suspected to have a history of retinal vasculitis or occlusive retinal vasculitis

Patients with neovascular glaucoma

Patients with a history of cerebral infarction or myocardial infarction within the past 6 months

Patients deemed inappropriate for inclusion at the discretion of the investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 30 Day Date of IRB - 2026 Year 01 Month 30 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2032 Year 02 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069230

Disclaimer: Curated by HT Syndication.