| CTRI Number |
CTRI/2024/11/076447 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Disorganisation of retinal Layers in predicting response to Anti-VEGF treatment in Diabetic Macular Edema. |
|
Scientific Title of Study
|
Disorganisation of inner vs outer retinal layers in predicting the response to ANTI-VEGF treatment in diabetic macular edema, an observational 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 |
DrSulatha V Bhandary |
| Designation |
Professor and Head of unit. |
| Affiliation |
Kasturba Medical College and Hospital, |
| Address |
Department Of Ophthalmology,
Kasturba Medical College and Hospital,
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9845264557 |
| Fax |
|
| Email |
sulatha.bhandary@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nadimpalli sushma |
| Designation |
junior resident |
| Affiliation |
Kasturba Medical College and Hospital, |
| Address |
Department Of Ophthalmology,
Kasturba Medical College and Hospital,
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8688821123 |
| Fax |
|
| Email |
nadimpalli.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
DrSulatha V Bhandary |
| Designation |
Professor and Head of unit. |
| Affiliation |
Kasturba Medical College and Hospital, |
| Address |
Department Of Ophthalmology,
Kasturba Medical College and Hospital,
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9845264557 |
| Fax |
|
| Email |
sulatha.bhandary@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Depatment of Ophthalmology , kasturba medical college, Manipal , Karnataka, India
pincode-576104 |
|
|
Primary Sponsor
|
| Name |
Department Of Ophthalmology , Kasturba Medical College , Manipal |
| Address |
OPD NO-25,
Kasturba Medical College,
Madhav Nagar, Manipal , Karnataka
India. pincode-576104 |
| 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 Sulatha V Bhandary |
Kasturba Medical College , Manipal |
Department Of Ophthalmology
kasturba medical college, Manipal
Manipal Academy of Higher Education,Manipal,karnataka,India-576104
Udupi KARNATAKA |
9845264557
sulatha.bhandary@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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, (2) ICD-10 Condition: E103||Type 1 diabetes mellitus with ophthalmic complications, (3) ICD-10 Condition: E093||Drug or chemical induced diabetesmellitus with ophthalmic complications, (4) ICD-10 Condition: E083||Diabetes mellitus due to underlying condition with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria-
1)All patients with Diabetic macular edema who underwent atleast 3 ANTI-VEGF (avastin-bevacizumab) whose 1 month post 3rd ANTI-VEGF injection OCT and vision was done from 1st jan 2022 to 20th may 2025 will be included.
|
|
| ExclusionCriteria |
| Details |
1)Patients without diabetes, baseline OCT and those younger than 18 years are excluded.
2)Patients with significant cataract, significant astigmatism, significant glaucoma that could effect OCT values will be excluded.
3) Patients with macular edema due to other causes will be excluded. Patients who have undergone macular lasers(grid etc.)will be excluded.
4)Patinets undergone treatment with OZURDEX will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| for the selected patients the baseline OCT,visual acuity and 1 month post 3 rd ANTI-VEFG (avastin-bevacizumab) injection visual acuity and OCT macula data will be collected from the medical records and interpreted .In addition to these other parameters like HBA1C, serum creatinine values will also be collected from medical records. |
1 month post 3 rd ANTI-VEGF injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="97" Sample Size from India="97"
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)
|
14/11/2024 |
| 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="1" Months="0" 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
|
This is Retrospective Observational study. in which Role of disorganization of inner vs outer retinal layers in predicting the response to ANTI-VEGF treatment in diabetic macular edema will be studied. · Permission to access the records in the medical records department will be taken from The Medical Superintendent. · Description of process :Step 1- to obtain IEC and CTRI clearance · Step 2- We will retrospectively review the medical records of patients who had who met the inclusion criteria will be selected from the medical records and will be included in the study .And patients falling under exclusion criteria will be xcluded · Step 3- for the selected patients the baseline OCT,visual acuity and 1 month post 3 rd ANTI-VEFG injection visual acuity and OCT macula data will be collected from the medical records .In addition to these other parameters like HBA1C, serum creatinine values will also be collected from medical records. · Outcome measures: Outcome measures include effect of retinal outer and inner layers morphology on visual acuity and central retinal thickness. · Potential risks and benefits: There is less than minimal risk for patient as it was purely an retrospective study in which we collect data from medical redords and we don’t alter or introduce any other tests other than treatment plan. In this study role of disorganisation of retinal inner vs outer layers of retina in predicting response to anti-VEGF treatment in DME will be studied which might aid in predicting the disease prognosis and disease management. · We will only review the records from the medical records department who fit the inclusion criteria and no active intervention will be done. |