| CTRI Number |
CTRI/2025/03/082400 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to assess the use of Triamcinolone acetonide injection in suprachoroidal space of eye for treatment of non infectious uveitis (an inflammatory disease of eye) |
|
Scientific Title of Study
|
Randomized clinical trial to assess the efficacy of Suprachoroidal Triamcinolone Acetate injection in Non-infectious Uveitis |
| 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 |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Dept of Ophthalmology
GSVM Medical College
Kanpur
Dept 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 Perwez Khan |
| Designation |
Professor |
| Affiliation |
GSVM Medical College Kanpur |
| Address |
Dept of Ophthalmology
GSVM Medical College
Kanpur
Dept of Ophthalmology
GSVM Medical College
Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9451875355 |
| Fax |
|
| Email |
perwezkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lubna Khan |
| Designation |
Professor |
| Affiliation |
GSVM Medical College |
| Address |
Dept of Pathology
GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8400331179 |
| Fax |
|
| Email |
lubnaperwez@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical College Swaroop Nagar,
Kanpur Nagar
208002
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Dr Perwez Khan |
| Address |
GSVM Medical College
Kanpur UP 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 Perwez Khan |
GSVM Medical College |
Department of Ophthalmology GSVM Medical College Kanpur Nagar 208002
Kanpur Nagar
UTTAR PRADESH |
9451875355
perwezkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H201||Chronic iridocyclitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Injection |
Sham injection with out any drug following all the intervention procedures will be given to comparator/ control eye. |
| Intervention |
Suprachoroidal injection of Triamcinolone Acetonide by indigenously designed suprachoroidal needle (Patent no 444428) |
Procedure will be done in operation theater. Intervention eye will be cleaned with Betadine 10% solution and eye drop Moxifloxacin 0.5% will used to ensure asepsis.
Castroviejo’s callipers will be used to mark desired spot approximately 4 mm from the limbus on temporal side. Preservative free triamcinolone acetonide 4 mg (0.1 ml of 40 mg/ml) will taken in 1 ml syringe and fitted with an indigenously designed suprachoroidal needle device (patent no 444428). The length of needle outside the cannula tip will be altered from 800 to 1000 micrometre depending upon the axial length of eyeball undergoing intervention. For axial length 23mm 1000 micrometre and for 23 mm 800 micrometre of length of needle outside the suprachoroidal cannula will be taken. Triamcinolone will be injected in suspension form at the precise spot after doing AC tap to overcome transient rise of intra ocular pressure. After injection eye-drop Moxifloxacin 0.5% will be put to prevent infection and eye will be patched. The patch will be removed 4- 6 hours later and eye-drop Moxifloxacin 0.5% QID will be instilled. Patient will be called for follow up on next day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed patients of all types (Anterior, intermediate, posterior and pan) uveitis
Patients who give informed consent for the study |
|
| ExclusionCriteria |
| Details |
uncontrolled glaucoma, uncontrolled diabetes, or any other active ocular disease or infection |
|
|
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 |
Improvement in visual acuity
Reduction in inflammation |
(0,1,3,15) day
(1,3,6) month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in central macular thickness |
0 day, 1 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
20/03/2025 |
| 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)
|
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
|
Uveitis is a group of intraocular inflammatory disorders affecting the uveal tract and surrounding tissues and is responsible for up to 15% of all cases of complete blindness in the developed world. It can be broadly classified as infectious and non-infectious uveitis (NIU). Each type is further classified based on anatomical location. Anterior uveitis is the most common entity comprising around 45%, followed by panuveitis (25%), while intermediate & posterior uveitis constitutes 15% of all cases. Treatment of posterior uveitis is difficult as delivering efficacious levels of therapeutic agents is challenging and can lead to visual morbidity. Control of inflammation, preventing sight-threatening complications and minimizing recurrences are the main therapeutic goals. The most common complication of chronic NIU is cystoid macular edema (CME) leading to vision impairment in one-third of all uveitis patients, followed by choroidal neovascularization (CNV). Macular edema may persist even after inflammation is controlled; therefore, interventions should aim to resolve both inflammation and macular edema. Present study is designed to study the role of triamcinolone acetonide injection in suprachoroidal space in different types of non-infectious uveitis for safety, efficacy, early recovery and prevention of relapse |