| CTRI Number |
CTRI/2024/10/076027 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To compare outcomes of injection Ranibizumab(anti-VEGF drug) vs laser therapy in the treatment of zone 2 threshold (severe form) of Retinopathy of Prematurity |
|
Scientific Title of Study
|
To compare outcomes of primary intravitreal Ranibizumab vs laser in treatment of zone 2 threshold Retinopathy of Prematurity |
| 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 Iekshiytha K |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Ward 3A, Unit 2, Retina Unit, Dr Rajebdra Prasad Centre for Ophthalmic Sciences, Ansari nagar, Aiims, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9947598747 |
| Fax |
|
| Email |
iekshiythak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parijat Chandra |
| Designation |
Professor of ophthalmology |
| Affiliation |
AIIMS New Delhi |
| Address |
Ward 3A, Unit 2, Retina Unit, Dr Rajebdra Prasad Centre for Ophthalmic Sciences, Ansari nagar, Aiims, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810019977 |
| Fax |
|
| Email |
parijatchandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Iekshiytha K |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Ward 3A, Unit 2, Retina Unit, Dr Rajebdra Prasad Centre for Ophthalmic Sciences, Ansari nagar, Aiims, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9947598747 |
| Fax |
|
| Email |
iekshiythak@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES, AIIMS, ANSARI NAGAR, NEW DELHI 110029 |
| JSSK Program, Ministry of health and family welfare, Govt of India, Nirman Bhawan, New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari nagar, New Delhi, India, 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 IEKSHIYTHA K |
DR RAJENDRA PRASAD CENTRE FOR OPHTHALMIC SCIENCES, AIIMS NEW DELHI |
WARD 3A, RPC CENTRE, ANSARI NAGAR NEW DELHI 110029
New Delhi
DELHI |
9947598747
iekshiythak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE, AIIMS NEW ELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Injection ranibizumab |
Dose is 0.25 MG in 0.025 ML and is given by intravitreal injection route. One time injection is given to patients.
|
| Comparator Agent |
Laser |
Laser treatment of avascular retina for photocoagulation under topical anaesthesia is done. We give one time laser to patients. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Month(s) |
| Gender |
Both |
| Details |
1. Gestational Age less than 34 weeks
2. Birth weight less than 2000 grams
3. Bigger babies 34-36 weeks or more than 2kg if high risk for developing ROP
4. Threshold ROP - Zone 2 Stage 3 ROP (5 Contiguous / 8 non contiguous clock hours) with plus disease
5. No previous ROP treatment
|
|
| ExclusionCriteria |
| Details |
1. Zone I and Zone III disease
2. Zone 2 disease less than threshold criteria
3. Advanced stage disease (stage 4/ 5 ROP)
4. Any other ocular abnormality
5. Systemically unfit for procedure
6. Parents not providing consent for study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
We assess for disease regression, progression or reactivation, extent of vascularization. We also assess the need for secondary intervention. We then compare these outcomes between groups which received primary intravitreal Ranibizumab vs laser in treatment of zone 2 threshold Retinopathy of Prematurity.
|
Follow up will be done at 1 week and then 2 weekly till 50 weeks PMA or complete disease regression |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a- To study need for additional treatment in both groups
b- To study the extent of revascularization, reactivation, PAR requiring treatment |
At 1 week & then 2 weekly till 50 weeks PMA or complete disease regression |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
07/11/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Retinopathy of prematurity is a neovascular retinal disorder of low-birth-weight premature babies that causes loss of vision by macular dragging and retinal detachment. ROP remains one of the leading causes of childhood blindness in both developed and developing countries.Threshold ROP is defined as 5 contiguous or 8 cumulative clock hours of stage 3 ROP in zone 1 or zone 2 with plus disease by ETROP guidelines5. It is a severe stage of ROP and has high risk of retinal detachment if left untreated.Argon and diode lasers are used to treat the avascular retina of threshold ROP. However, laser often leads to progression, need for additional treatment, and often ends in sequelae with vision reduction. Laser of the avascular retina has delayed effect and there is risk of progression. Primary Anti-VEGF injections can lead to rapid ROP regression without sequelae, with the benefit of additional revascularization, preventing need for additional treatment. There is a need to assess outcomes of primary Anti-VEGF vs laser in threshold ROP |