Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058082) titled 'Evaluation of high-dose aflibercept therapy, aqueous humor cytokine changes, and prognostic factors in patients with age-related macular degeneration' on Jan. 1.

Study Type: Observational

Primary Sponsor: Institute - Nagoya University Hospital

Condition: Condition - Neovascular age-related macular degeneration Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the efficacy of high-dose aflibercept therapy for neovascular age-related macular degeneration and to analyze cytokine concentrations in aqueous humor obtained at the initiation of treatment. By examining their associations with clinical outcomes such as visual acuity, central retinal thickness, and lesion size, the study seeks to identify potential prognostic biomarkers. In addition, by comparing aqueous humor cytokine profiles between nAMD eyes and control eyes undergoing cataract surgery, the study aims to identify disease-specific cytokine alterations. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male Key inclusion criteria - nAMD group: Patients diagnosed with age-related macular degeneration who will receive high-dose aflibercept treatment

Control group: Patients undergoing ophthalmic surgery Key exclusion criteria - Cases with comorbid inflammatory diseases such as uveitis Cases that have undergone treatment at another institution with insufficient clinical details Cases in which aqueous humor sampling via anterior chamber paracentesis is judged to be unsafe Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 04 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2028 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066382

Disclaimer: Curated by HT Syndication.