Clinical trial NCT05576792: A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of Prematurity
ROP
NIS
China
ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 62
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female preterm infants with confirmed diagnosis of bilateral ROP who require treatment in China

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

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Incidence of AEs
timeFrame: Up to 24 weeks
measure: Assessment of length
timeFrame: Baseline, Week 12, and Week 24
measure: Assessment of weight
timeFrame: Baseline, Week 12, and Week 24
measure: Assessment of head circumference
timeFrame: Baseline, Week 12, and Week 24
measure: Assessment of lower leg length
timeFrame: Baseline, Week 12, and Week 24
measure: Time to intervention with a second modality for ROP or development of unfavorable structural outcome
timeFrame: Up to 24 weeks
measure: Proportion of participants with re-treatment of ROP receiving any post-baseline intervention
timeFrame: 24 weeks
measure: number of ranibizumab administrations needed in the treatment of participants with ROP
timeFrame: 24 weeks
measure: Full retinal vascularization in 12 clock hours
timeFrame: Week 24
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: