計劃書編號VGFTe-ROP-1920
試驗已結束
2021-04-13 - 2022-03-08
Phase III
終止收納3
一項隨機分配、對照、多中心試驗，針對早產兒視網膜病變的患者，評估玻璃體內注射Aflibercept 相較於雷射光凝療法治療的療效、安全性及耐受性
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
早產兒視網膜病變
試驗目的
這項試驗的主要目標為評估aflibercept 相較於雷射用於診斷為ROP患者的療效。
本試驗的次要目標為：
• 評估第二種治療模式的需要
• 評估試驗中ROP 復發的情況
• 評估aflibercept 的安全性與耐受性
本試驗的探索性目標為：
• 進一步分析在ROP 患者中Aflibercept 治療的解剖學效果
• 進一步研究與本疾病流程相關的試驗介入治療(例如：作用方式相關的影響及/或安全性)
• 評估aflibercept 和雷射的治療負荷
• 分析血漿中游離和結合態Aflibercept 濃度隨時間的變化
• 說明Aflibercept 的潛在免疫原性
藥品名稱
Solution for intravitreal injection
主成份
Aflibercept
劑型
Solution for intravitreal injection
劑量
mg/mL
評估指標
主要試驗指標為依據試驗主持人判斷，在實際年齡52 週歲時無活性
ROP 和結構結果不良的患者比例。針對兩眼皆納入試驗的患者，兩眼都必須達到試驗指標。
結構結果不良的定義為視網膜剝離、黃斑部牽引、黃斑部皺褶、或晶狀體後混濁。
ROP 和結構結果不良的患者比例。針對兩眼皆納入試驗的患者，兩眼都必須達到試驗指標。
結構結果不良的定義為視網膜剝離、黃斑部牽引、黃斑部皺褶、或晶狀體後混濁。
主要納入條件
7.2.1. Inclusion Criteria
A patient must meet the following criteria at screening and baseline to be eligible for inclusion in
the study:
1. Gestational age at birth ≤32 weeks or birth weight ≤1500 g
2. Patients with treatment-naïve ROP classified according to the International Classification
for ROP in at least one eye as:
Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
Zone II Stage 2 plus or 3 plus, or
AP-ROP
3. Weight at baseline (day of treatment) ≥800 g
4. Male or female
5. Signed informed consent from parent(s)/legally authorized representative(s) as described
in Section 13.2, which includes compliance with the requirements and restrictions listed in
the informed consent form (ICF) and in this protocol.
A patient must meet the following criteria at screening and baseline to be eligible for inclusion in
the study:
1. Gestational age at birth ≤32 weeks or birth weight ≤1500 g
2. Patients with treatment-naïve ROP classified according to the International Classification
for ROP in at least one eye as:
Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or
Zone II Stage 2 plus or 3 plus, or
AP-ROP
3. Weight at baseline (day of treatment) ≥800 g
4. Male or female
5. Signed informed consent from parent(s)/legally authorized representative(s) as described
in Section 13.2, which includes compliance with the requirements and restrictions listed in
the informed consent form (ICF) and in this protocol.
主要排除條件
7.2.2. Exclusion Criteria
A patient who meets any of the following criteria will be excluded from the study:
1. Known or suspected chromosomal abnormality, genetic disorder, or syndrome
2. Previous exposure to any IVT or systemic anti-VEGF agent, including maternal exposure
during pregnancy and/or during breastfeeding
3. Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or
higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic
nerve function, severe hydrocephalus with significantly increased intracranial pressure)
4. Pediatric conditions rendering the infant ineligible for study intervention at baseline or for
repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study
ophthalmologist
5. Presence of active ocular infection within 5 days of the first treatment
6. Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and
stage 5)
7. ROP involving only Zone III
8. Ocular abnormalities that may interfere with the administration of study intervention or
assessment of the study primary endpoint
9. Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of
prednisone ≥1 mg/kg/day for ＞2 weeks within 14 days of the first study intervention
10. Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative
laser therapy, cryotherapy, and vitrectomy)
11. Participation of the patient or the mother in other clinical trials requiring administration of
investigational treatments (other than vitamins and minerals) at the time of screening, or
within 30 days or 5 half-lives of administration of the previous study drug, whichever is
longer
A patient who meets any of the following criteria will be excluded from the study:
1. Known or suspected chromosomal abnormality, genetic disorder, or syndrome
2. Previous exposure to any IVT or systemic anti-VEGF agent, including maternal exposure
during pregnancy and/or during breastfeeding
3. Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or
higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic
nerve function, severe hydrocephalus with significantly increased intracranial pressure)
4. Pediatric conditions rendering the infant ineligible for study intervention at baseline or for
repeated blood draws as evaluated by a neonatal intensive care unit specialist and a study
ophthalmologist
5. Presence of active ocular infection within 5 days of the first treatment
6. Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and
stage 5)
7. ROP involving only Zone III
8. Ocular abnormalities that may interfere with the administration of study intervention or
assessment of the study primary endpoint
9. Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of
prednisone ≥1 mg/kg/day for ＞2 weeks within 14 days of the first study intervention
10. Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative
laser therapy, cryotherapy, and vitrectomy)
11. Participation of the patient or the mother in other clinical trials requiring administration of
investigational treatments (other than vitamins and minerals) at the time of screening, or
within 30 days or 5 half-lives of administration of the previous study drug, whichever is
longer
試驗計畫預計收納受試者人數
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台灣人數
1 人
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全球人數
127 人
