Comparative study of two treatments via different routes in patients of age related macular degeneration, a potentially blinding disease in old age population

Phase 3

Not yet recruiting

Conditions: Chorioretinal disorders in diseases classified elsewhere,

Registration Number: CTRI/2025/05/087843

Lead Sponsor: GSVM MEDICAL COLLEGE

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early resolution of choroidal neovascular tissue	Baseline, 7th day, 15th day, 1 month, 2nd month, 3rd month
Early and sustained improvement in Best Corrected Visual Acuity (BCVA)	Baseline, 7th day, 15th day, 1 month, 2nd month, 3rd month

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): GSVM Medical College
🇮🇳
Nagar, UTTAR PRADESH, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Dr Garima Singh
Principal investigator
8299860862
garimasachan18@gmail.com