| CTRI Number |
CTRI/2025/08/093657 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Intraocular pressure changes after intravitreal Anti-VEGF injection in Retinopathy of Prematurity |
|
Scientific Title of Study
|
The effect of intravitreal anti-vascular endothelial growth factor injection on intraocular pressure for 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 Siddharth Madan |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology Maulana Azad Medical College Guru Nanak Eye Centre
Central
DELHI
110002
India |
| Phone |
9711212928 |
| Fax |
|
| Email |
drsiddharthmadan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishita Yadav |
| Designation |
PG student |
| Affiliation |
Department of Ophthalmology Maulana Azad Medical College Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology Maulana Azad Medical College Guru Nanak Eye Centre
Central
DELHI
110002
India |
| Phone |
7497016573 |
| Fax |
|
| Email |
ryrocketindia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rishita Yadav |
| Designation |
PG student |
| Affiliation |
Department of Ophthalmology Maulana Azad Medical College Guru Nanak Eye Centre |
| Address |
Department of Ophthalmology Maulana Azad Medical College Guru Nanak Eye Centre
Central
DELHI
110002
India |
| Phone |
7497016573 |
| Fax |
|
| Email |
ryrocketindia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology Guru Nanak Eye Centre Maulana
Azad Medical College gnec.delhi.gov.in
Guru Nanak Eye Centre
Maharaja Ranjit Singh Marg New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College Guru Nanak Eye Centre |
| Address |
Maulana Azad Medical College Guru Nanak Eye Centre
110002
New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Rishita Yadav |
Guru Nanak Eye Centre |
ROOM NO-102 Department of Ophthalmology Maulana Azad Medical College New Delhi PIN-110002
Central
DELHI |
07497016573
ryrocketindia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics Committee |
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 |
Intra vitreal Anti-Vascular Endothelial Growth Factor Inhibitor |
dose- 0.25 mg/0.025 ml
route- Intravitreal
Frequency- Once |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Aggressive ROP (AROP)
Zone 1 any stage with plus disease
Zone 2 stage2/3 with plus disease.
|
|
| ExclusionCriteria |
| Details |
• Prior history of anti-VEGF injection
• Prior treatment with laser for ROP
• Any Known hypersensitivity for anti-VEGF injection
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in IOP measured by iCare tonometer at 5 minutes, 15 minutes or until IOP normalizes, on post injection day 1 in the eye receiving intravitreal anti-VEGF injection of ranibizumab under topical anesthesia. |
5 minutes
15 minutes
post injection Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in IOP measured by iCare tonometer at 1 & 3 months in the eye receiving intravitreal anti-VEGF injection of Ranibizumab under topical anesthesia.
2. Response to treatment in terms of serial change in zone & stage of ROP from baseline with or without additional treatment.
|
1 month
3 month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/09/2025 |
| 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="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 a prospective interventional study to evaluate the effect of intravitreal Ranibizumab injection on intraocular pressure in premature infants with retinopathy of prematurity The primary outcome is to evaluate the change in intraocular pressure before and after injection and during follow-up up to 3 months. Secondary outcomes include the treatment response in terms of regression or progression of disease and the influence of maternal and neonatal risk factors |