Last Update: Sep 11, 2023
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:
Novartis Reference Number:CRFB002H2403
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. Eligible participants treated according to local routine clinical practice will be
enrolled in the study upon signing an Informed Consent.

Participants will enter the study when they receive their first treatment and are
followed up for 24 weeks. During the follow up period, participants could receive
post-baseline treatment (i.e., ranibizumab or laser therapy) Patients will be treated
according to the approved label and standard of care and as per Investigator judgement.

End of study will be defined as completion of the week 24 visit or premature withdrawal
visit

Retinopathy of Prematurity
Recruiting
55
Jan 13, 2023
Dec 30, 2024
All
- (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:

1. Signed informed consent from parent(s) or legal guardian(s), in compliance with
local requirements

2. Male or female preterm infants with a birth weight of less than 1500 g

3. 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:

1. 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

2. Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either
the patient or the mother during this child's pregnancy)

3. 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

4. Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative
laser therapy or cryotherapy, vitrectomy)

5. Participants who have contraindications according to locally approved ranibizumab
label

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