A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China

A 24-week, Open-label, Prospective, Single-arm Study Evaluating the Effectiveness and Safety of Lucentis® (Ranibizumab) 0.2mg in Retinopathy of Prematurity (ROP) Participants in China

ClinicalTrials.gov Identifier: NCT05576792

Novartis Reference Number: CRFB002H2403

Last Update: Jan 26, 2023

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.

Condition 
Retinopathy of Prematurity
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jan 13, 2023
Completion date 
May 16, 2024
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Other
Ranibizumab
Prospective observational study. There is no treatment allocation. Patients prescribed with ranibizumab 0.2 mg in the commercial setting are eligible to enroll into this study.

Eligibility Criteria

Inclusion Criteria:

Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
Male or female preterm infants with a birth weight of less than 1500 g

Bilateral ROP with 1 of the following retinal findings in each eye:

Zone I, stage 1+, 2+, 3 or 3+ disease, or
Zone II, stage 3+ disease, or
A-ROP

Exclusion Criteria:

Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
Participants who have contraindications according to locally approved ranibizumab label

Study Locations

China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Hangzhou, 310014
Zhejiang
China
Novartis Investigative Site
Recruiting
Shanghai, 200092
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 
[email protected]

Have a question?

Call 1-888-669-6682 or email [email protected]