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

NCT05576792 | Completed

• 1 other identifier: CRFB002H2403
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; ROP; NIS; China; ranibizumab

Outcome Measures

Primary Outcomes (1)

• Number of participants with absence of active Retinopathy of Prematurity (ROP) and absence of unfavorable structural outcomes in both eyes during the observational period after starting study treatment.

  To achieve this outcome, participants cannot fulfill any of the following criteria: * Require intervention for ROP in either eye at or before the 24week assessment visit with a treatment modality other than ranibizumab * Have active ROP in either eye at the 24week assessment visit * Have unfavorable structural outcomes in either eye at or before 24-week assessment visit

  Week 24

Secondary Outcomes (9)

• Incidence of AEs

  Up to 24 weeks

• Assessment of length

  Baseline, Week 12, and Week 24

• Assessment of weight

  Baseline, Week 12, and Week 24

• Assessment of head circumference

  Baseline, Week 12, and Week 24

• Assessment of lower leg length

  Baseline, Week 12, and Week 24

Study Arms (1)

ranibizumab 0.2 mg

Intravitreal ranibizumab 0.2 mg for the treatment of ROP

Other: Ranibizumab

Interventions

Ranibizumab 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.

ranibizumab 0.2 mg

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female preterm infants with confirmed diagnosis of bilateral ROP who require treatment in China

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Guangzhou, Guangdong, 510000, China

Location

Related Links

• Results for CRFB002H2403 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: January 13, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)