| CTRI Number |
CTRI/2025/08/092489 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Two Different Eye Injections for Premature Babies with Retinal Problem |
|
Scientific Title of Study
|
Comparison of Intravitreal Ranibizumab Versus Aflibercept for Treatment of Retinopathy of Prematurity- A Pilot Randomized Clinical Trial
|
| 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 Devesh Kumawat |
| Designation |
Assistant Professor, Ophthalmology |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
| Address |
Room S2, First Floor, Department of Ophthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9711797688 |
| Fax |
|
| Email |
deveshkumawat21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Sharma |
| Designation |
Junior Resident, Ophthalmology |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
| Address |
Room S2, First Floor, Department of Ophthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9560745150 |
| Fax |
|
| Email |
abhaygoku.00753@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumawat |
| Designation |
Assistant Professor, Ophthalmology |
| Affiliation |
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
| Address |
Room S2, First Floor, Department of Ophthalmology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9711797688 |
| Fax |
|
| Email |
deveshkumawat21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi India 110029
For Material/ Infrastructure support |
| Janani Shishu Suraksha Karyakram (JSSK), Ministry of Health and Family Welfare, Nirman Bhavan, Delhi, India 110011
GOVERNMENT FUNDING |
|
|
Primary Sponsor
|
| Name |
Janani Shishu Suraksha Karyakram |
| Address |
Ministry of Health and Family Welfare, Nirman Bhavan, Delhi, India 110011 |
| Type of Sponsor |
Government funding agency |
|
|
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 Devesh Kumawat |
AIIMS Delhi |
Room 148, ROP Clinic, First floor, Dr. Rajendra PrasadCentre for Ophthalmic Sciences, AIIMS, Ansari Nagar 110029
South West
DELHI |
9711797688
deveshkumawat21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Post Graduate Research, AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H351||Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aflibercept Injection |
Intravitreal injection of Aflibercept in type 1 ROP-
Dose- 0.4mg/0.01ml, Frequency- Once, Route- Intravitreal injection, Follow-up- Till 20 weeks after injection |
| Comparator Agent |
Ranibizumab injection |
Intravitreal injection of Ranibizumab in type 1 ROP-
Dose- 0.2mg/0.02ml, Frequency- Once, Route- Intravitreal injection, Follow-up- Till 20 weeks after injection |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
1. Zone 1 or zone 2 posterior Type 1 Retinopathy of prematurity (ROP) including aggressive ROP
2. Bilaterally symmetrical disease
3. Treatment naive cases
4. Signed informed consent from parent/ guardian
|
|
| ExclusionCriteria |
| Details |
1. Type 2 ROP
2. Zone 2 anterior or zone 3 disease
3. Stage 4 or 5 disease
4. Corneal or lenticular opacities or vitreous haemorrhage obscuring assessment
5. Pediatric conditions rendering the infant ineligible for intervention
6. Active ocular infection rendering the infant ineligible for intervention
7. Parents not willing or giving consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of eyes developing reactivation of disease following intravitreal ranibizumab versus aflibercept injection in zone 1 or zone 2 posterior type 1 ROP |
20 weeks post injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to reactivation following injection |
Till 20 weeks post injection |
| Type of reactivation following injection |
Till 20 weeks post injection |
| Time to regression of acute phase ROP following injection |
Till 20 weeks post injection |
| Extent of vascularisation at the time of reactivation |
Till 20 weeks post injection |
| Extent of vascularisation at final visit |
20 weeks post injection |
| Need for additional treatment |
Till 20 weeks post injection |
| Refractive error at last visit |
20 weeks post injection |
| Anatomical outcome at last visit |
20 weeks post injection |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/08/2025 |
| 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="1"
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
|
Title of Study:
A Pilot Randomized Controlled Trial Comparing Intravitreal Ranibizumab Versus Aflibercept for Treatment of Type 1 Retinopathy of Prematurity Brief Summary:
This is a single-center, parallel-group, outcome-assessor blinded, pilot randomized controlled trial designed to compare the efficacy and safety of intravitreal ranibizumab (0.2 mg/0.02 ml) versus aflibercept (0.4 mg/0.01 ml) in the treatment of Type 1 Retinopathy of Prematurity (ROP), including aggressive ROP, in infants with bilaterally symmetrical, treatment-naive disease affecting Zone 1 or posterior Zone 2 retina. A total of 20 eyes (10 infants) will be enrolled per group. The primary objective is to assess disease regression, recurrence rate, and time to recurrence. Secondary outcomes include extent of retinal vascularization, persistent avascular retina, refractive error at last follow-up, anatomical outcome, and any ocular or systemic adverse events. Infants will be followed for 20 weeks post-treatment. Randomization will be done using a computer-generated sequence with allocation concealment. This study aims to generate preliminary data to guide a larger future trial. Primary Objective:
To compare the rates of disease regression and recurrence between ranibizumab and aflibercept in infants with Type 1 ROP. Secondary Objectives:
To assess retinal vascularization, incidence of persistent avascular retina, refractive outcomes, anatomical results, and adverse events following anti-VEGF treatment. Study Design:
Pilot randomized controlled trial; parallel group; outcome-assessor blinded Study Duration:
18 months (12 months recruitment + 6 months follow-up) Sample Size:
20 eyes (10 infants) per group Intervention Arms: Inclusion Criteria: -
Type 1 ROP (Zone 1 or Zone 2 posterior), including AROP -
Bilaterally symmetrical, treatment-naive disease -
Informed consent from parent/guardian Exclusion Criteria: Study Site:
ROP Clinic, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India Follow-up Schedule:
Day 1, Day 3, Week 2, then every 2 weeks up to 20 weeks post-treatment. Digital imaging and refraction at designated intervals. Trial Registration Category:
Interventional (Clinical Trial of a Drug) Funding Source:
Janani Shishu Suraksha Karyakram (JSSK), Government of India |