| CTRI Number |
CTRI/2024/10/075960 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of dexamethasone implant in previously untreated eye of a diabetic patient |
|
Scientific Title of Study
|
Intravitreal dexamethasone implant (ozurdex) in the management of treatment naive 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 |
Hamna Asharaf |
| Designation |
Primary DNB |
| Affiliation |
Sankara eye hospital |
| Address |
Sankara eye hospital,
Sathy road, saravanampatti,
Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9995261356 |
| Fax |
|
| Email |
dr.hamna94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. M Prabhu Shanker |
| Designation |
Consultant |
| Affiliation |
Sankara eye hospital |
| Address |
Sankara eye hospital,
Sathy road, saravanampatti,
Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9443186568 |
| Fax |
|
| Email |
drprabhushanker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hamna Asharaf |
| Designation |
Primary DNB |
| Affiliation |
Sankara eye hospital |
| Address |
Sankara eye hospital,
Sathy road, saravanampatti,
Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9995261356 |
| Fax |
|
| Email |
dr.hamna94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital,
Sathy road
Saravanampatti, Coimbatore
Tamilnadu
India
Pin: 641035 |
|
|
Primary Sponsor
|
| Name |
Hamna Asharaf |
| Address |
Sankara eye hospital
Sathy road, Saravanampatti
Coimbatore
Tamilnadu
India
Pin:641035 |
| 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 |
| Hamna Asharaf |
Sankara eye hospital |
Room no.8
Department of vitreo-retinal surgery
Department of ophthalmology
Coimbatore
TAMIL NADU |
9995261356
dr.hamna94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sankara eye y |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone implant (ozurdex) |
0.7mg intravitreal injection once in 4 months over a period of 1 year |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
HbA1c less than or equal to 9g %
Type 1 and Type 2 Diabetes Mellitus
Age more than 40yrs
Well controlled blood pressure |
|
| ExclusionCriteria |
| Details |
Previously treated Diabetic macular edema patients
Other ocular comorbidities- glaucoma, ocular hypertension, ocular pathologies
Previous retinal surgery
History of previous intra-vitreal injection for any other ocular diseases |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in BCVA assessed by Snellens chart |
1 week, 1 month and 3 months after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in macular thickness as assessed by OCT |
1 week, 1 month and 3 months after treatment. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2024 |
| Date of Study Completion (India) |
19/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patients with diabetes develop endothelial dysfunction which causes leakage of retinal microvasculature.
The elevated pro- inflammatory cytokines and reduced anti inflammatory cytokines predispose to extravasation of fluid from the retinal vessels leading to diabetic macular edema.
Initially, laser photo-coagulation was the mainstay of treatment, but it has limited effect in restoring vision.
Anti-VEGF, although found effective, has the disadvantage of requiring frequent injection and follow up.
Intra-vitreal corticosteroid implant overcomes the disadvantage of frequent dosing and the associated frequent injection related complications .Dexamethasone is a corticosteroid and has actions at the level of nucleus and gene expression.
Corticosteroids prevents new vessel formation by suppressing angiogenic factors, including VEGF. It also increases the level of anti-inflammatory proteins. It maintains the integrity of tight junctions of the blood retinal barrier and also promotes clearance of retinal fluids.
Ozurdex, containing 0.7mg dexamethasone, is biodegradable drug approved for treating diabetic macular edema and releases dexamethasone into the vitreous over a period of ≤6 month.
This thesis evaluates the efficacy of dexamethasone intra-vitreal implant in the management of treatment naive diabetic macular edema.
|