A multicentre, open-label, prospective, single-arm, non-comparative, non-randomized phase IV study to evaluate safety and efficacy of Injection Ranibizumab (of Sponsor Lupin Limited) given as intravitreal injection in preterm infants with Retinopathy of Prematurity
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- To assess the safety and tolerability of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity.
研究概览
简要总结
This is a multicentre, open label, single arm, phase IV study to evaluate safety and efficacy of Ranibizumab given as intravitreal injection in preterm infants with Retinopathy of Prematurity.
As per standard dosing regimen, Ranibizumab of Lupin Limited, 0.2 mg will be administered as a single intravitreal injection per eye to all eligible patients as per the eligibility criteria.
Total duration of study will be approximately 93 days including the Screening period of 5 days, and treatment and assessment period of 85 days wherein,
Screening will be done on Visit 1, Day -4 to Day 0
Dosing as single injection per day in the affected eye on Visit 2, Day 1
Note - As per investigator’s discretion, 2 additional injections or reinjection may be given with an interval of 4 weeks between 2 injections
Safety Assessments and examinations on Day 2 , Day 8 , Day 29 and Day 5
EOS visit on Day 85 including all the end of the study safety assessments and study activities.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •Unilateral or Bilateral ROP with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.
- •Infants- Weighing less than 2000 grams or Infants less than 34 weeks of gestation
- •At baseline the weight of the infants should be more than or equal to 800 gm.
- •Informed consent provided by the parents or legal guardians of the patient for participation in the study.
排除标准
- •ROP disease characteristic in either eye other than that listed above at the time of the first dosing of the study drug.
- •A history of hypersensitivity (either the patient or the mother) to any of the excipients or active pharmaceutical ingredients or to drugs of similar chemical classes or any known allergies due to any drug or other allergies.
- •Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
- •Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during pregnancy)
- •Had 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 was longer
- •Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
- •Had active ocular infection within 5 days before or on the day of first dosing or active or suspected ocular or periocular infection or active intraocular inflammation
- •Had a history of hydrocephalus requiring treatment
- •Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
- •Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule).
结局指标
主要结局
To assess the safety and tolerability of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity.
时间窗: safety assessment and Fundus examination will be performed on | Visit 3, Day 2 (week 1) | Visit 4, Day 8 (week 2) | Visit 5, Day 29 (week 5) | Visit 6, Day 57 (week 9) and | Visit 7, Day 85, (week 13)
次要结局
- To assess the efficacy of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity.(Efficacy will be assessed by)