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

Retinopathy of Prematurity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576792
• Other study ID #: CRFB002H2403
• Status: Recruiting
• Start date: January 13, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Changchun	Jilin
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Hangzhou	Zhejiang
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Zhengzhou City	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of AEs	Incidence of AEs will be collected	Up to 24 weeks
Secondary	Assessment of length	For the assessment of length the participant should be wearing minimal clothing (e.g., a clean diaper). Recumbent length in centimeters will be measured using an infantometer or according to local clinical practice.	Baseline, Week 12, and Week 24
Secondary	Assessment of weight	For the assessment of weight the participant should be wearing minimal clothing (e.g., a clean diaper). Body weight to the nearest gram will be measured using an electronic scale.	Baseline, Week 12, and Week 24
Secondary	Assessment of head circumference	For the assessment of head circumference the participant should be wearing minimal clothing (e.g., a clean diaper). The maximum occipitofrontal head circumference in centimeters will be measured using a tape measure.	Baseline, Week 12, and Week 24
Secondary	Assessment of lower leg length	For the assessment of lower leg length the participant should be wearing minimal clothing (e.g., a clean diaper).The lower leg length (knee-heel length) will be measured to the nearest 0.1 centimeter using a sliding caliper or according to local clinical practice. Measurements should always be done on the right side, unless a physical deformity affects the right side.	Baseline, Week 12, and Week 24
Secondary	Time to intervention with a second modality for ROP or development of unfavorable structural outcome	Time to intervention with a second modality for ROP or development of unfavorable structural outcome will be collected	Up to 24 weeks
Secondary	Proportion of participants with re-treatment of ROP receiving any post-baseline intervention	Proportion of participants with re-treatment of ROP receiving any post-baseline intervention at or before 24 weeks	24 weeks
Secondary	number of ranibizumab administrations needed in the treatment of participants with ROP	number of ranibizumab administrations needed in the treatment of participants with ROP will be collected	24 weeks
Secondary	Full retinal vascularization in 12 clock hours	Full retinal vascularization in 12 clock hours at the 24-week assessment to evaluate fundus features of ranibizumab 0.2 mg in the treatment of ROP	Week 24