| CTRI Number |
CTRI/2025/03/081840 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Intravitreal triamcinolone acetonide(steroid) injection for the treatment of retinal disease |
|
Scientific Title of Study
|
Intravitreal triamcinolone acetonide injection for the treatment of cystoid macular edema in patients presenting to tertiary eye care center of central india:A prospective study |
| 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.Shweta sanjiv chopade |
| Designation |
Junior resident ophthalmology |
| Affiliation |
Government medical college,Nagpur. |
| Address |
Department of ophthalmology,government medical college nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08767191353 |
| Fax |
|
| Email |
shwetachopade63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kavita Dhabarde |
| Designation |
Head of department and associate professsor |
| Affiliation |
Government medical college,Nagpur. |
| Address |
Department of ophthalmology,government medical college nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9423105181 |
| Fax |
|
| Email |
drkavitad1423@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shweta sanjiv chopade |
| Designation |
Junior resident ophthalmology |
| Affiliation |
Government medical college,Nagpur. |
| Address |
Department of ophthalmology,government medical college nagpur.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08767191353 |
| Fax |
|
| Email |
shwetachopade63@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college,Nagpur,Maharashtra,INDIA,440003 |
|
|
Primary Sponsor
|
| Name |
Shweta sanjiv chopade |
| Address |
mard resident hostel,GMCH nagpur college campus,Nagpur.440003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shweta Sanjiv Chopade |
Government medical college,Nagpur |
Department of ophthalmology,OPD No. 84, Government medical college,Nagpur
Nagpur
MAHARASHTRA |
08767191353
shwetachopade63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee,GMCH,Nagpur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravitreal triamcinolone acetonide injection 4mg/ 0.1ml |
intravitreal triamcinolone acetonide injection 4mg/ 0.1ml intravitreal route of administratin in pars plana area,given monthly injection till macular edema subsides for 3months. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with cystoid macular edema.
patients willing to participate. |
|
| ExclusionCriteria |
| Details |
Patients with history of glaucoma.
history of eye injury |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| central macular thickness and visual acuity. |
4 weeks ,3months,6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in best corrected visual acuity. |
at day 1,15th day,4weeks & 3months,6months |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
study of effect and complications of use of intravitreal triamcinolone acetonide injection for treatment of cystoid macular edema in non affording population at tertiary eye care centre central india. triamcinolone acetonide being affordable steroid compared with anti VEGF agents use for its anti-inflammatory action to reduce macular edema in patients with macular edema. Its use to improve visual acuity by reducing edema and complications associated with it are being studied in this study. |