| CTRI Number |
CTRI/2025/03/082947 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Comparative study for the efficacy of aflibercept and dexamethasone implant in treatment naive macular edema with serous retinal detachment |
|
Scientific Title of Study
|
Comparative efficacy of Aflibercept and dexamethasone implant in treatment naive diabetic macular edema with serous retinal detachment:A prospective 6 month followup 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 Manglesh Mohan Gupta |
| Designation |
Fellow |
| Affiliation |
Nethradhama super speciality eye hospital |
| Address |
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar
Bangalore
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
manglesh11222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Kapoor |
| Designation |
Consultant vitreous retina |
| Affiliation |
Nethradhama super speciality eye hospital |
| Address |
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar
Bangalore
KARNATAKA
560070
India |
| Phone |
9811866335 |
| Fax |
|
| Email |
dr.monika.kapoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Kapoor |
| Designation |
Consultant vitreous retina |
| Affiliation |
Nethradhama super speciality eye hospital |
| Address |
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar
Bangalore
KARNATAKA
560070
India |
| Phone |
9811866335 |
| Fax |
|
| Email |
dr.monika.kapoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar |
|
|
Primary Sponsor
|
| Name |
Nethradhama education research foundation |
| Address |
Retina Department, 1st floor, SPC block, Nethradhama eye hospital, Kanakpura road,7th block, Jayanagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manglesh Mohan Gupta |
Nethradhama super speciality eye hospital |
Retina Department, SPC Block, 1st floor, Nethradhama eye hospital, kanakpura road,7th block Jayanagar Bangalore
Bangalore
KARNATAKA |
9503586623
manglesh1122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alfliebrrcept and Dexamethasone implant |
Aflibercept 2mg/0.05ml intravitreal dose, duration 10mins
Dexamethasone implant 0.7mg, intravitreal implant, intravitreal injection, duration 10mins |
| Intervention |
Intravitreal antivegf |
Intravitreal anti vegf injection |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of DME treatment naive , Central retinal thickness more than 250 micrometer |
|
| ExclusionCriteria |
| Details |
Prior intervention of disease
allergy to drug |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of mean central retinal thickness and mean change from baseline in Central retinal thickness and serous retinal detachment |
Baseline, 1,3,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Best corrected visual acuity |
Baseline, 1 ,3, 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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 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
|
Comparing the efficacy of Anti VEGF with steroid injection in newly diagnosed casea of Diabetic macular edema with Serous retinal detachment. To check which injection gives better response with less number of injections. |