FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.














 
Close