| CTRI Number |
CTRI/2025/05/087763 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the role of suprachoroidal triamcinolone acetate (corticosteroid) injection in patients with diabetic retinopathy and diabetic macular edema |
|
Scientific Title of Study
|
To study the role of suprachoroidal triamcinolone acetate injection in patients with diabetic retinopathy and diabetic macular edema |
| 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 Ophthalmology
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 Deepak Kumar |
| Designation |
Junior Resident |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Ophthalmology
GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9793899874 |
| Fax |
|
| Email |
dkboss9793@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar |
| Designation |
junior resident |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Department of Ophthalmology
GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9793899874 |
| Fax |
|
| Email |
dkboss9793@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
GSVM Medical College Kanpur |
| Address |
Department of Ophthalmology
GSVM Medical College Kanpur |
| 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 Deepak Kumar |
GSVM Medical College Kanpur |
Department of Ophthalmology GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH |
9793899874
dkboss9793@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: H350||Background retinopathy and retinalvascular changes, (2) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham injection |
Under aseptic conditions (using 0.5% betadine 10% solution) The control eye will be anesthetised by eyedrop Proparacaine.
Next with the help of Vernier’s callipers the desired spot approximately 3.5-4.5 mm from the limbus on temporal side will be marked.
Then single Sham injection will be given suprachoroidaly at the precise spot. After injection eyedrop moxifloxacin 0.5% will be put to prevent infection and eye will be patched.
The patch will be removed after 4-6 hours and eyedrop moxifloxacin 0.5% qid will be instilled to prevent infection.
|
| Intervention |
Suprachoroidal injection of Triamcinolone accetate |
Under aseptic conditions (using 0.5% betadine 10% solution) The subject eye will be anesthetised by eyedrop Proparacaine.
Next with the help of Vernier’s callipers the desired spot approximately 3.5-4.5 mm from the limbus on temporal side will be marked.
Then single injection of Triamcinolone Acetate 1ml (40mg/ml) will be given suprachoroidaly at the precise spot. After injection eyedrop moxifloxacin 0.5% will be put to prevent infection and eye will be patched.
The patch will be removed after 4-6 hours and eyedrop moxifloxacin 0.5% qid will be instilled to prevent infection.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate or ready for followup for at least 6 months.
All patients of diabetic retinopathy and macular edema on FFA & OCT.
|
|
| ExclusionCriteria |
| Details |
Patients not willing to participate or ready for followup.
Patients with HTN (160/110mmHg)
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 diabetic retinopathy and diabetic macular edema.
Diabetic retinopathy old case of Diabetic Macular Edema.
Patients having severe, very severe diabetic retinopathy, proliferative diabetic retinopathy and diabetic macular edema |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in best corrected visual acuity
|
0, 1 month, 2 month, 3 month 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in macular edema |
pre intervention 1 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
30/06/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Present study will be conducted to assess the effect of Suprachoroidal
Triamcinolone Acetate in cessation of progression of diabetic retinopathy and
diabetic macular edema. Eyes of the patients will be randomized into
intervention and control group. Intervention eye will receive suprachoroidal injection
of triamcinolone acetate with the help of indigenously designed suprachoroidal
needle. Control eye will receive sham injection. Injections will be given at
the time of presentation and will be repeated at 1 month and 2 months.
Visual recovery will be assessed by early treatment diabetic retinopathy
scale (ETDRS) at presentation, 1 month, 2 months, 3 months and 6 months, and
resolution of edema will be assessed by OCT at presentation, 1 month and 6
months. Fundus fluorescein angiography will be performed at presentation, 1
month, 2 months, 3 months and 6 months to assess retinal blood vessels.
Safety of monthly suprachoroidal Triamcinolone Acetate will be assessed
by measuring intra ocular pressure, fundus examination, blood sugar levels both
fasting and post prandial, HbA1c at presentation, 1 month, 2 months, 3 months
and 6 months.
|