A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ranibizumab 0.2 mg Intravitreal ranibizumab 0.2 mg for the treatment of ROP |
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.
|
Outcome Measures
Primary Outcome Measures
- 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. [Week 24]
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
Secondary Outcome Measures
- Incidence of AEs [Up to 24 weeks]
Incidence of AEs will be collected
- Assessment of length [Baseline, Week 12, and Week 24]
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.
- Assessment of weight [Baseline, Week 12, and Week 24]
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.
- Assessment of head circumference [Baseline, Week 12, and Week 24]
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.
- Assessment of lower leg length [Baseline, Week 12, and Week 24]
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.
- Time to intervention with a second modality for ROP or development of unfavorable structural outcome [Up to 24 weeks]
Time to intervention with a second modality for ROP or development of unfavorable structural outcome will be collected
- Proportion of participants with re-treatment of ROP receiving any post-baseline intervention [24 weeks]
Proportion of participants with re-treatment of ROP receiving any post-baseline intervention at or before 24 weeks
- number of ranibizumab administrations needed in the treatment of participants with ROP [24 weeks]
number of ranibizumab administrations needed in the treatment of participants with ROP will be collected
- Full retinal vascularization in 12 clock hours [Week 24]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
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Male or female preterm infants with a birth weight of less than 1500 g
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Bilateral ROP with 1 of the following retinal findings in each eye:
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Zone I, stage 1+, 2+, 3 or 3+ disease, or
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Zone II, stage 3+ disease, or
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A-ROP
Exclusion Criteria:
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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
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Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
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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
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Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
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Participants who have contraindications according to locally approved ranibizumab label
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Chengdu | Sichuan | China | 610041 |
| 2 | Novartis Investigative Site | Hangzhou | Zhejiang | China | 310014 |
| 3 | Novartis Investigative Site | Shanghai | China | 200092 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRFB002H2403