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A clinical trial to study the effects of two different doses of Intravitreal Ranibizumab in patients with Aggressive Posterior Retinopathy of Prematuriy.

To compare the outcomes of 0.1mg and 0.25mg of intravitreal Ranibizumab in the management of Aggressive Posterior Retinopathy of Prematurity.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026347
Enrollment
15
Registered
2020-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: Single Intravitreal injection of Ranibizumab 0.1mg in 0.01ml in one eye.: Eyes will be randomized. Single Injection of Ranibizumab 0.1mg in 0.01 ml will be administered in the vitreous

Sponsors

Dr Rajendra Prasad Centre for Ophthalmic Science All India Institute of Medical Science New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pre-term babies (Gestational Age 2. Birth Weight 3. Zone I â?? Zone II Posterior APROP 4. Bilateral symmetrical disease

Exclusion criteria

Exclusion criteria: 1. Advanced stage disease (stage 4/ 5 ROP) 2. Zone II anterior and Zone III disease (non-APROP) 3. Any previous intervention done (Laser/ Anti-VEGF) 4. Any other ocular abnormality

Design outcomes

Primary

MeasureTime frame
To study disease regression with two different doses of intravitreal Ranibizumab in APROP.Timepoint: Week 1,2,4,8,12—

Secondary

MeasureTime frame
Need for additional interventionTimepoint: Week 1, 2, 4, 8 and 12;To observe the extent of re-vascularisation of retina Timepoint: Compared Pre-injection (Day 0) and Post-injection week 8—

Countries

India

Contacts

Public ContactManasi Tripathi

Department of Ophthalmology, All India Institute of Medical Science, New Delhi

parijatchandra@gmail.com9810019977

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026