Overview

Rainbow Extension Study

Status:
Active, not recruiting
Trial end date:
2022-05-18
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Ranibizumab
Criteria
Inclusion Criteria:

- The patient successfully completed the core study CRFB002H2301

- The patient received study treatment in both eyes at baseline of study CRFB002H2301

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