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临床试验/CTRI/2025/05/087843
CTRI/2025/05/087843尚未招募3 期

A Comparative analysis of intravitreal anti VEGF monotherapy and intravitreal anti VEGF combined with suprachoroidal triamcinolone in patients of wet age related macular degeneration (AMD)

GSVM MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Early resolution of choroidal neovascular tissue

研究概览

简要总结

Age-related macular degeneration is a leading cause of vision loss especially in older adults due to damage in the central part of the retina. AMD is categorized into early intermediate and late stages with late-stage AMD divided into two forms dry  and wet . While dry AMD is more common wet AMD is more aggressive and involves the growth of abnormal blood vessels under the retina triggered by vascular endothelial growth factor . These new blood vessels are fragile and tend to leak fluid or blood, causing swelling, damage to retinal cells, and permanent vision impairment. Optical coherence tomography  is widely used to assess AMD progression revealing signs like drusen retinal pigment epithelium  irregularities and fluid accumulation. In wet AMD OCT often shows a break in the RPE Bruch membrane and abnormal vessel growth. The suprachoroidal space is a potential gap between the sclera and choroid it was traditionally difficult to visualize but can now be seen using modern imaging techniques like EDIOCT and swept-source OCT.  Delivering medication via the SCS is a promising alternative to traditional methods like intravitreal injections. While intravitreal therapy is effective it carries risks such as infection retinal detachment and systemic absorption. The SCS approach may reduce these risks by targeting drug delivery to the retina and choroid more precisely. It also allows for larger volumes potentially leading to longerlasting effects and fewer injections.

This method involves injecting drugs such as triamcinolone into the SCS using microneedles that penetrate only as far as needed to reach the space. This minimally invasive technique avoids intraocular complications and shows promise for more efficient treatment of retinal diseases including wet AMD.To evaluate the efficacy of suprachoroidal triamcinolone acetonide injection using a patented, indigenously designed micro-needle in the management of wet age-related macular degeneration  and to compare its therapeutic outcomes with standard intravitreal antiVEGF monotherapy. this is a prospective interventional study to be conducted at GSVM Medical College, Kanpur, involving  60 patients aged over 50 years with newly diagnosed wet AMD. Participants are randomized into two groups one receiving intravitreal antiVEGF alone and the other receiving combined intravitreal antiVEGF with suprachoroidal triamcinolone. The suprachoroidal injection was administered using a custom-designed micro-needle. All patients underwent baseline and follow-up assessments including visual acuity OCT IOP measurement and fundus evaluation. Follow-up was done up to 3 months post-treatment. The study is designed to determine whether the combined approach offers superior anatomical and functional outcomes compared to anti VEGF alone potentially reducing injection frequency and improving patient comfort. Final results will guide future treatment protocols for wet AMD.

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
51.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed patients of Wet ARMD on FFA and OCT pattients giving consent and willing for follow up.

排除标准

  • Patients with raised RBS levels (more than 200mg/dl).
  • Patients with any ocular infection, raised Intraocular pressure (IOP), any corneal pathology, thinned sclera, scleritis, staphyloma, or any other anterior segment pathology except Pseudophakic patients.
  • Patients diagnosed of any other retinal or vitreous pathologies except wet ARMD.

结局指标

主要结局

Early resolution of choroidal neovascular tissue

时间窗: Baseline, 7th day, 15th day, 1 month, 2nd month, 3rd month

Early and sustained improvement in Best Corrected Visual Acuity (BCVA)

时间窗: Baseline, 7th day, 15th day, 1 month, 2nd month, 3rd month

次要结局

未报告次要终点

研究者

发起方
GSVM MEDICAL COLLEGE
申办方类型
Government medical college

研究点 (1)

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