| CTRI Number |
CTRI/2025/05/087843 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of two treatments via different routes in patients of age related macular degeneration, a potentially blinding disease in old age population |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Perwez Khan |
| Designation |
Professor and head of department |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Ophthalmolgy
GSVM Medical College Kanpur
Kanpur Nagar UTTAR PRADESH 208002 India |
| Phone |
9451875355 |
| Fax |
|
| Email |
perwezkhan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Garima Singh |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Ophthalmology
GSVM Medical College Kanpur
Kanpur Nagar UTTAR PRADESH 208002 India |
| Phone |
8299860862 |
| Fax |
|
| Email |
garimasachan18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Garima Singh |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Ophthalmology
GSVM Medical College Kanpur
Kanpur Nagar UTTAR PRADESH 208002 India |
| Phone |
8299860862 |
| Fax |
|
| Email |
garimasachan18@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical College Kanpur UP 208002 India |
|
|
Primary Sponsor
|
| Name |
GSVM MEDICAL COLLEGE |
| Address |
SWAROOP NAGAR KANPUR UP 208002 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Garima Singh |
GSVM Medical College |
Department of Ophthalmology Kanpur Nagar UTTAR PRADESH |
8299860862
garimasachan18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GSVM MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H32||Chorioretinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj intravitreal anti VEGF ranbizumab |
Single injection of intravireal ranibizumab 0.05 ml will be given |
| Intervention |
inj intravitreal anti VEGF ranibizumab and inj suprachoroidal triamcenolone acetonide |
Single injection of 0.05 ml ranibizumab will be given intravitreally and 0.1 ml of triamcinolone will be given in suprachoridal space using a indigenously designed microneedle |
|
|
Inclusion Criteria
|
| Age From |
51.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of Wet ARMD on FFA and OCT
pattients giving consent and willing for follow up
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Early resolution of choroidal neovascular tissue
Early and sustained improvement in Best Corrected Visual Acuity (BCVA) |
Baseline, 7th day, 15th day, 1 month, 2nd month, 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
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