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CTRI Number  CTRI/2023/06/054362 [Registered on: 23/06/2023] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare effect of Injection Ranibizumab 0.25 mg versus Injection Aflibercept 1mg in infants of Retinopathy of Prematurity. 
Scientific Title of Study   To compare effect of Inj ranibizumab0.25mg versus inj Aflibercept 1mg in Retinopathy of Prematurity. 
Trial Acronym  Ranibizumab versus aflibercept in ROP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lt Col Pradeep Kumar 
Designation  Classified specialist (Advisor) 
Affiliation  Army Hospital Referral and Research 
Address  Department of visual and ophthalmic sciences Army Hospital Referral and research Delhi

New Delhi
DELHI
110010
India 
Phone  9560034515  
Fax    
Email  eyepradeep@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Lt Col Pradeep Kumar 
Designation  Classified specialist (Advisor) 
Affiliation  Army Hospital Referral and Research 
Address  Department of visual and ophthalmic sciences Army Hospital Referral and research Delhi

New Delhi
DELHI
110010
India 
Phone  9560034515  
Fax    
Email  eyepradeep@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Lt Col Pradeep Kumar 
Designation  Classified specialist (Advisor) 
Affiliation  Army Hospital Referral and Research 
Address  Department of visual and ophthalmic sciences Army Hospital Referral and research Delhi

New Delhi
DELHI
110010
India 
Phone  9560034515  
Fax    
Email  eyepradeep@yahoo.com  
 
Source of Monetary or Material Support  
Army Hospital Referral and Research Department of ophthalmology Dhaula Kuan , DELHI CANTT 
 
Primary Sponsor  
Name  Army Hospital Referral and Research  
Address  Army hospital Referral and Research Dhaula Kuan Delhi cantt New delhi  
Type of Sponsor  Research institution and hospital 
 
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 
DrNavjyot kaur  Army Hospital Referral and Research   Department of ophthalmology
New Delhi
DELHI 		 9805292853

navjyotvasistha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Army Hospital (R&R), Delhi Cantt  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H351||Retinopathy of prematurity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj AFLIBERCEPT 1 mg   Intravitreal Injection AFLIBERCEPT 1 mg in Retinopathy of prematurity in newborn for up to 45 weeks of preconceptional age 
Intervention  Injection RANIBIZUMAB 0.25 mg  Intravitreal Inj RANIBIZUMAB 0.25 mg in Retinopathy of prematurity in newborns for up to 45 weeks of preconceptional age 
 
Inclusion Criteria  
Age From  28.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  Premature newborns of APROP (aggressive posterior rop) and Hybrid ROP which is presence of ridge tissue, characteristic of staged ROP along with flat neovascular syncytium, and character of APROP in same eye. 
 
ExclusionCriteria 
Details  Patients with stage 4 and stage 5 ROP
Patients with pre existing ocular disease like congenital cataract, congenital glaucoma and other retinopathy  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Regression of ROP in-terms of change in percentage of vascularised retina  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of re injection
Recurrence after injection
Time duration before re injection  		 4 weeks 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   30/06/2023 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [navjyotvasistha@gmail.com].

  6. For how long will this data be available start date provided 30-06-2023 and end date provided 28-02-2123?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is a randomised, double blind, parallel group, single centre clinical trial comparing the efficacy of Intravitreal Inj Ranibizumab 0.25 mg versus Intravitreal Inj Aflibercept 1 mg in 124 eye, 62 prematurely newborn patients of Retinopathy of Prematurity that will be conducted at Army hospital Referral and Research, Delhi Cantt. in India. The primary outcome in terms of regression of ROP in terms of percentage of vascularised retina in 4 weeks. The secondary outcome will be measured in terms requirement of re Injection and time duration before re injection and recurrence after injection measured at 4 weeks and 8 weeks after injection. 
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