Clinical Trial: Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors (Japan)

Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059703) titled 'Efficacy of brolucizumab for diabetic macular edema and identification of treatment-resistant factors' on Nov. 8.

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 - Diabetic macular edema Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of the treat-and-extend regimen with brolucizumab in diabetic macular edema. Additionally, to analyze various laboratory data, imaging data, and intraocular cytokines to investigate factors contributing to treatment resistance and discontinuation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Brolucizumab intravitreal injection Aqueous humor collection

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients diagnosed with DME (regardless of severity) 2) Patients aged 20 years or older (regardless of gender) 3) Patients with untreated DME 4) Outpatients 5) Patients who have provided written informed consent to participate in this study 6) Patients with baseline corrected visual acuity between 0.8 and 0.05 7) Patients who selected the brolucizumab treat and extend regimen Key exclusion criteria - 1) Active intraocular or periorbital infection; history of idiopathic/autoimmune uveitis 2) Cases suspected of having a history of retinal vasculitis/occlusive retinal vasculitis 3) Neovascular glaucoma 4) Cerebral infarction/myocardial infarction within the past 6 months 5) Undergoing dialysis 6) Severe hypersensitivity to fluorescein or iodine 7) Patients deemed unsuitable for the study at the physician's discretion Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 30 Day Date of IRB - 2025 Year 11 Month 03 Day Anticipated trial start date - 2025 Year 11 Month 08 Day Last follow-up date - 2031 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068286

Disclaimer: Curated by HT Syndication.