| CTRI Number |
CTRI/2024/04/065549 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Imaging biomarkers in diabetic patients with retinal oedema treated on intravitreal anti-VEGF |
|
Scientific Title of Study
|
Disorganization of retinal inner layers as a biomarker in patients with center involving diabetic macular oedema treated with intravitreal bevacizumab |
| 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 Deepa Ajitkumar |
| Designation |
Assistant Professor |
| Affiliation |
N KP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Ophthalmology
N K P Salve Institute of Medical Sciences and research center and Lata Mangeshkar Hospital, Nagpur ,Maharashtra, India
Nanded
MAHARASHTRA
440019
India |
| Phone |
7775950155 |
| Fax |
|
| Email |
deepa.ajitkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Ajitkumar |
| Designation |
Assistant Professor |
| Affiliation |
N KP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Ophthalmology
N K P Salve Institute of Medical Sciences and research center and Lata Mangeshkar Hospital, Nagpur ,Maharashtra, India
MAHARASHTRA
440019
India |
| Phone |
7775950155 |
| Fax |
|
| Email |
deepa.ajitkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Ajitkumar |
| Designation |
Assistant Professor |
| Affiliation |
N KP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Ophthalmology
N K P Salve Institute of Medical Sciences and research center and Lata Mangeshkar Hospital, Nagpur ,Maharashtra, India
MAHARASHTRA
440019
India |
| Phone |
7775950155 |
| Fax |
|
| Email |
deepa.ajitkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| N K P Salve Institute of Medical Sciences & Research centre and Lata Mangehkar Hospital
|
|
|
Primary Sponsor
|
| Name |
N K P Salve Institute of Medical Sciences and Research Centre , Nagpur |
| Address |
Nagpur
Maharashtra |
| Type of Sponsor |
Private 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 Deepa Ajitkumar |
N K P Salve Institute of Medical Sciences & Research Centre and Lata Mangeshkar Hospital , Nagpur |
Room no. 4
Department of Ophthalmology
Nagpur
MAHARASHTRA |
7775950155
deepa.ajitkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H357||Separation of retinal layers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years of age, compliant for follow-up and willing to participate
2. Patients of type I and type II Diabetes mellitus presenting with diabetic macular oedema resulting in visual loss
3. Study eye having best corrected visual acuity of less than 6/12. Macular oedema defined clinically and by SD- OCT as retinal thickness of more than 250µm in the central sub-field and presence of intra or sub-retinal fluid .
4. Treatment with intravitreal bevacizumab (atleast one injection) in past 6 months.
|
|
| ExclusionCriteria |
| Details |
1. Other retinal diseases which can cause macular oedema like retinal vascular disorders, choroidal neovascular membrane secondary to age related macular degeneration or any other cause, uveitis
2. Recent history of any intraocular surgery leading to macular oedema
3. Any other cause of loss of visual acuity except cataract
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • The correlation between DRIL and functional (BCVA) and anatomical (CST) outcomes over 6 months. |
• The correlation between DRIL and functional (BCVA) and anatomical (CST) outcomes over 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The change in DRIL after treatment with intra vitreal bevacizumab and the correlation between patients’ clinical and OCT measures and DRIL during the study period. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
25/04/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Diabetic macular oedema (DME) is a sight threatening complication of Diabetic Retinopathy, affecting more than 20% patients of long-standing Diabetes. Anti vascular endothelial growth factor injections are the first line treatment for DME which improves visual acuity and resolves macular oedema in majority of patients. Optical coherence tomography is an indispensable tool for the diagnosis, treatment and follow-up of patients with DME. Sun et.al in 2014 showed a new morphologic feature on SD-OCT known as disorganization of retinal inner layers ( DRIL) in cases of DME. Disorganization of retinal inner layers (DRIL) essentially describes the inability to delineate the inner retinal layer boundaries within the central retina.Amelioration of DRIL after 4 months treatment with anti-VEGF in eyes with DME was found to be predictive for better visual outcome in DME after 12 months[8]. DRIL seen on fewer OCT scans was shown to be associated with good VA after resolution of centre-involving DME . A recent study further solidified the importance of DRIL as a relevant noninvasive biomarker by demonstrating an association between DRIL and increasing severity of diabetic retinopathy While the association between the presence of DRIL and VA has been well established, it has not been reported before if current treatment measures are able to affect the severity of DRIL. Purpose: To investigate disorganization of retinal inner layers as a biomarker in eyes with centre involving diabetic macular oedema treated with intravitreal bevacizumab.
|