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临床试验/CTRI/2025/03/082400
CTRI/2025/03/082400招募中3 期

Randomized clinical trial to assess the efficacy of Suprachoroidal Triamcinolone Acetate injection in Non-infectious Uveitis

Dr Perwez Khan1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
196
试验地点
1
主要终点
Improvement in visual acuity

研究概览

简要总结

Uveitis is a group of intraocular inflammatory disorders affecting the uveal tract and surrounding tissues and is responsible for up to 15% of all cases of complete blindness in the developed world. It can be broadly classified as infectious and non-infectious uveitis (NIU). Each type is further classified based on anatomical location. Anterior uveitis is the most common entity comprising around 45%, followed by panuveitis (25%), while intermediate & posterior uveitis constitutes 15% of all cases.

Treatment of posterior uveitis is difficult as delivering efficacious levels of therapeutic agents is challenging and can lead to visual morbidity. Control of inflammation, preventing sight-threatening complications and minimizing recurrences are the main therapeutic goals. The most common complication of chronic NIU is cystoid macular edema (CME) leading to vision impairment in one-third of all uveitis patients, followed by choroidal neovascularization (CNV). Macular edema may persist even after inflammation is controlled; therefore, interventions should aim to resolve both inflammation and macular edema.

Present study is designed to study the role of triamcinolone acetonide injection in suprachoroidal space in different types of non-infectious uveitis for safety, efficacy, early recovery and prevention of relapse

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed patients of all types (Anterior, intermediate, posterior and pan) uveitis Patients who give informed consent for the study.

排除标准

  • uncontrolled glaucoma, uncontrolled diabetes, or any other active ocular disease or infection.

结局指标

主要结局

Improvement in visual acuity

时间窗: (0,1,3,15) day | (1,3,6) month

Reduction in inflammation

时间窗: (0,1,3,15) day | (1,3,6) month

次要结局

  • Reduction in central macular thickness(0 day, 1 month, 6 month)

研究者

发起方
Dr Perwez Khan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Perwez Khan

GSVM Medical College Kanpur

研究点 (1)

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