| CTRI Number |
CTRI/2022/03/040844 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
02/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of visual outcome between two different Intraocular injections for swelling of nerve tissue of eye in patients with Intraocular lens |
|
Scientific Title of Study
|
Comparative study of Retinal Sensitivity through Microperimetry post intravitreal Avastin vs intravitreal triamcinolone acetonide for diabetic macular edema in pseudophakic eyes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameer Chaudhary |
| Designation |
MS Resident - II |
| Affiliation |
Aravind Eye Hospital, Madurai |
| Address |
Aravind Eye Hospital, Madurai, Anna Nagar, Madurai, Tamil Nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
9958702003 |
| Fax |
|
| Email |
sameerchaudhary22@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kim Ramasay |
| Designation |
Chief medical officer |
| Affiliation |
Aravind Eye Hospital, Madurai |
| Address |
Aravind Eye Hospital, Madurai, Anna Nagar, Madurai, Tamil Nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356100 |
| Fax |
|
| Email |
kim@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Sameer Chaudhary |
| Designation |
MS Resident - II |
| Affiliation |
Aravind Eye Hospital, Madurai |
| Address |
Aravind Eye Hospital, Madurai, Anna Nagar, Madurai, Tamil Nadu
Madurai
TAMIL NADU
625020
India |
| Phone |
9958702003 |
| Fax |
|
| Email |
sameerchaudhary22@outlook.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Madurai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
NIl |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Sameer |
Aravind Eye Hospital, Madurai |
Aravind Eye Hospital, Anna Nagar, Madurai, Tamil Nadu, India - 625020
Madurai
TAMIL NADU |
9958702003
sameerchaudhary22@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital Institutional Ethics Committee |
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 |
Intravitreal injection - Bevacizumab (Avastin) |
1.25 mg of bevacizumab marketed by the name of Avastin will be injected intravitreally following PRN regimen
First injection will be given at first visit and if indicated, subsequent injections will given at 1 monthly interval |
| Comparator Agent |
Intravitreal injection - Triamcinolone acetonide |
4mg of Triamcinolone acetonide will be injected intravitreally following PRN regimen.
First injection will be given at first visit and if indicated, subsequent injections will given at 3 monthly interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Central subfield retinal thickness of at least 300um measured by OCT
2. Centre involving macular edema
3. Visual acuity between 6/9 to 6/60
|
|
| ExclusionCriteria |
| Details |
1. Previous treatment in terms of : -
a) Focal/macular photocoagulation
b) Previous intravitreal injection therapy - Last 3 months
c) PRP in the last 6 months
2. Any medial opacity obscuring the fundus view
3. Intra ocular pressure >21mmHg or previous steroid responders
4. Cataract surgery and YAG capsulotomy in the last 3 months
5. PDRP patients requiring simultaneous pan-retinal photocoagulation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measurement and comparison of average threshold for macular sensitivity via microperimetry between the two treatment arms
|
0, 1, 6 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measurement and comparison of VA (snellen’s 3 metre), CSRT (OCT), fixation characteristics (microperimetry) and number of injections given between the two treatment arms
|
0, 1, 6 month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
15/03/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetic retinopathy is a disease of the nervous tissue in the eye resulting uncontrolled diabetes mellitus. A common complication of this is diabetic macular edema, which is accumulation of fluid in this nervous tissue and causes significant vision loss.
In this study, we compare two commonly used drugs - Bevacizumab (Anti VEGF) and Triamcinolone acetonide (steroid) given inside the eye (intravitreally) to resolve this edema to see which is more effective
Most studies comparing these two drugs, compare the outcome using two parameters. First is visual acuity representing functional outcome and second is thickness of this nervous tissue representing anatomical outcome
In our study, we are using retinal sensitivity, which represent how sensitive the nervous tissue is to the light, as the functional outcome. The macular retinal sensitivity is measured using microperimetry and has shown to be a better parameter to evaluate functional outcomes when compared to visual acuity. |