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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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