CompletedNot Applicable

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

China62 participantsStarted 2023-01-13

Plain-language 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.

Who can participate

Age range0 Days

SexALL

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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:

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

What they're measuring

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.

Timeframe: Week 24

Trial details

NCT IDNCT05576792

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-10

View on ClinicalTrials.gov More Retinopathy of Prematurity trials