This study is to determine if ranibizumab injected into the eye is superior to laser therapy in the treatment of retinopathy of prematurity (ROP). The study will assess the ability of these treatments to lead to regression of active ROP and prevent the development of ocular complications that are associated with poor visual outcome.
Phase 1
- Conditions
- Retinopathy of Prematurity (ROP)MedDRA version: 20.1Level: PTClassification code 10038933Term: Retinopathy of prematuritySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-004048-36-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
The patient successfully completed the core study CRFB002H2301
The patient received study treatment in both eyes at baseline of study CRFB002H2301
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patient has a medical condition or personal circumstance which precludes study participation or compliance with study procedures, as assessed by the Investigator
Patient has been discontinued from the core study CRFB002H2301 at any time
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess visual function of the better seeing eye;Secondary Objective: To assess:<br>- number of patients having any ocular Adverse Event<br>- number of patients having any systemic Adverse Event<br>- visual function of the worse seeing eye<br>- absence of active Retinopathy of Prematurity <br>- absence of ocular structural abnormalities<br>- recurrence of ROP<br>- number of Lucentis administrations<br>- refraction in each eye<br>- standing/sitting height and leg length<br>- weight<br>- head circumference<br>- respiratory function<br>- hearing function<br>- duration of hospitalization<br>- weight at first hospital discharge;Primary end point(s): Visual acuity (VA) in the better-seeing eye ;Timepoint(s) of evaluation of this end point: VA is being assessed at the patient's fifth birthday.
- Secondary Outcome Measures
Name Time Method