Comparison of Intravitreal Ranibizumab Versus Aflibercept for Treatment of Retinopathy of Prematurity- A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of eyes developing reactivation of disease following intravitreal ranibizumab versus aflibercept injection in zone 1 or zone 2 posterior type 1 ROP
研究概览
简要总结
Title of Study: A Pilot Randomized Controlled Trial Comparing Intravitreal Ranibizumab Versus Aflibercept for Treatment of Type 1 Retinopathy of Prematurity
Brief Summary: This is a single-center, parallel-group, outcome-assessor blinded, pilot randomized controlled trial designed to compare the efficacy and safety of intravitreal ranibizumab (0.2 mg/0.02 ml) versus aflibercept (0.4 mg/0.01 ml) in the treatment of Type 1 Retinopathy of Prematurity (ROP), including aggressive ROP, in infants with bilaterally symmetrical, treatment-naive disease affecting Zone 1 or posterior Zone 2 retina. A total of 20 eyes (10 infants) will be enrolled per group. The primary objective is to assess disease regression, recurrence rate, and time to recurrence. Secondary outcomes include extent of retinal vascularization, persistent avascular retina, refractive error at last follow-up, anatomical outcome, and any ocular or systemic adverse events. Infants will be followed for 20 weeks post-treatment. Randomization will be done using a computer-generated sequence with allocation concealment. This study aims to generate preliminary data to guide a larger future trial.
Primary Objective: To compare the rates of disease regression and recurrence between ranibizumab and aflibercept in infants with Type 1 ROP.
Secondary Objectives: To assess retinal vascularization, incidence of persistent avascular retina, refractive outcomes, anatomical results, and adverse events following anti-VEGF treatment.
Study Design: Pilot randomized controlled trial; parallel group; outcome-assessor blinded
Study Duration: 18 months (12 months recruitment + 6 months follow-up)
Sample Size: 20 eyes (10 infants) per group
Intervention Arms:
- Group A: Intravitreal Ranibizumab 0.2 mg/0.02 ml
- Group B: Intravitreal Aflibercept 0.4 mg/0.01 ml
Inclusion Criteria:
- Type 1 ROP (Zone 1 or Zone 2 posterior), including AROP
- Bilaterally symmetrical, treatment-naive disease
- Informed consent from parent/guardian
Exclusion Criteria:
- Type 2 or anterior ROP
- Stage 4 or 5 disease
- Media opacity preventing fundus view
- Significant systemic illness or ocular infection
Study Site: ROP Clinic, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi, India
Follow-up Schedule: Day 1, Day 3, Week 2, then every 2 weeks up to 20 weeks post-treatment. Digital imaging and refraction at designated intervals.
Trial Registration Category: Interventional (Clinical Trial of a Drug)
Funding Source: Janani Shishu Suraksha Karyakram (JSSK), Government of India
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 2.00 Month(s)（—）
- 性别
- All
入选标准
- •Zone 1 or zone 2 posterior Type 1 Retinopathy of prematurity (ROP) including aggressive ROP
- •Bilaterally symmetrical disease
- •Treatment naive cases
- •Signed informed consent from parent/ guardian.
排除标准
- •Type 2 ROP
- •Zone 2 anterior or zone 3 disease
- •Stage 4 or 5 disease
- •Corneal or lenticular opacities or vitreous haemorrhage obscuring assessment
- •Pediatric conditions rendering the infant ineligible for intervention
- •Active ocular infection rendering the infant ineligible for intervention
- •Parents not willing or giving consent.
结局指标
主要结局
Proportion of eyes developing reactivation of disease following intravitreal ranibizumab versus aflibercept injection in zone 1 or zone 2 posterior type 1 ROP
时间窗: 20 weeks post injection
次要结局
- Time to reactivation following injection(Till 20 weeks post injection)
- Type of reactivation following injection(Till 20 weeks post injection)
- Time to regression of acute phase ROP following injection(Till 20 weeks post injection)
- Extent of vascularisation at the time of reactivation(Till 20 weeks post injection)
- Extent of vascularisation at final visit(20 weeks post injection)
- Need for additional treatment(Till 20 weeks post injection)
- Refractive error at last visit(20 weeks post injection)
- Anatomical outcome at last visit(20 weeks post injection)
研究者
Dr Devesh Kumawat
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi