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

NCT ID: NCT05576792

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-13
• Study Completion Date: 2024-07-10

Brief Summary

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.

Detailed Description

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

Conditions

Retinopathy of Prematurity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ranibizumab 0.2 mg

Intravitreal ranibizumab 0.2 mg for the treatment of ROP

Ranibizumab

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 0 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Guangzhou, Guangdong, China

Countries

China

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18264

Results for CRFB002H2403 from the Novartis Clinical Trials Website

Other Identifiers

CRFB002H2403

Identifier Type: -

Identifier Source: org_study_id