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CTRI Number  CTRI/2025/12/098727 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   How body inflammation and eye scan changes help predict treatment results in patients with diabetic eye swelling.” 
Scientific Title of Study   Comparison of Systemic Inflammation and OCT-Based Biomarkers in Patients with Diabetic Macular Edema and Their Role in Predicting Treatment Outcomes After Ranibizumab Injection 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anita Kukreja 
Designation  PhD. Research Scholar 
Affiliation  JSS AHER Medical College 
Address  Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka-570004
Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka-570004
Mysore
KARNATAKA
570004
India 
Phone  08860393817  
Fax    
Email  24pbm025@jssuni.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumya H V 
Designation  HOD Professor and Guide 
Affiliation  JSS Medical College Hospital 
Address  Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka-570004
Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka-570004
Mysore
KARNATAKA
570004
India 
Phone  9448116151  
Fax    
Email  soumyahv@jssuni.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Soumya H V 
Designation  HOD Professor and Guide 
Affiliation  JSS Medical College Hospital 
Address  Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka-570004
Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka-570004
Mysore
KARNATAKA
570004
India 
Phone  9448116151  
Fax    
Email  soumyahv@jssuni.edu.in  
 
Source of Monetary or Material Support  
JSS Hospital and Medical College 
 
Primary Sponsor  
Name  Anita Kukreja 
Address  Ophthalmology Department, JSS Medical College Hospital, M. G. Road, Mysore, Karnataka, India-570004 
Type of Sponsor  Other [self] 
 
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 
Anita Kukreja  JSS Medical College Hospital  Ophthalmology Department, M. G. Road, Mysore, Karnataka-570004
Mysore
KARNATAKA 		 08860393817

24pbm025@jssuni.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSSMC/IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  confirmed diagnosis of DME with intraretinal fluid or subretinal fluid on OCT 
 
ExclusionCriteria 
Details  previous intraocular surgery within 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in OCT-based biomarkers, central subfield thickness, and presence of pre- and post-ranibizumab injection
correlation between systemic inflammatory markers NLR, PLR, and treatment response at 3 and 6 months 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
  2 years 
 
Target Sample Size   Total Sample Size="322"
Sample Size from India="302" 
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)   23/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [24pbm025@jssuni.edu.in].

  6. For how long will this data be available start date provided 23-12-2025 and end date provided 08-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A significant correlation exists between OCT-based biomarkers and systemic inflammatory indices in patients with diabetic macular edema, which may aid in predicting treatment outcomes. 
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