Clinical Trials List
Protocol NumberVGFTe-ROP-1920
NCT Number(ClinicalTrials.gov Identfier)NCT04101721
2020-08-30 - 2022-04-30
Phase III
Recruiting3
Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients with Retinopathy of Prematurity
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Regeneron Pharmaceuticals
-
Trial scale
Multi-Regional Multi-Center
-
Update
2023/03/10
Investigators and Locations
Co-Principal Investigator
- Li-chung Chi 未分科
- Hsiu-Lin Chen 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳冠任 未分科
- 傅仁煇 未分科
- 朱世明 未分科
- 陳彥伯 未分科
- 孫銘輝 未分科
- Jen Fu Hsu 未分科
- Yih-Shiou Hwang 未分科
- Chun-Hsiu Liu 未分科
- 江明洲 未分科
- 周宏達 未分科
- 林瑞瑩 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Retinopathy of Prematurity
Objectives
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in
patients diagnosed with ROP.
The secondary objectives of the study are:
• To assess the need for a second treatment modality
• To assess the recurrence of ROP in the study
• To assess the safety and tolerability of aflibercept
The exploratory objectives of the study are:
• To further characterize the anatomical effects of treatment with aflibercept in patients
with ROP
• To further investigate the study intervention (eg, mode-of-action-related effects and/or
safety) relevant to this disease process
• To assess the treatment burden of aflibercept and laser
• To characterize the concentrations of free and bound aflibercept in plasma over time
To describe the potential immunogenicity of aflibercept
Test Drug
Eylea
Active Ingredient
Aflibercept
Dosage Form
Solution for intravitreal injection
Dosage
40
Endpoints
The primary endpoint is the proportion of patients with absence of active ROP and of unfavorable
structural outcomes at week 52 of chronological age, as determined by the Investigator. For
patients with both eyes enrolled in the study, both eyes must meet the endpoint.
Unfavorable structural outcomes are defined as retinal detachment, macular dragging, macular
fold, or retrolental opacity.
The secondary endpoints are:
• Proportion of patients requiring intervention with a second treatment modality from
baseline to week 52 of chronological age
• Proportion of patients with recurrence of ROP through week 52 of chronological age
• The proportion of patients with treatment-emergent adverse events (TEAEs) and
serious adverse events (SAEs) (ocular and systemic) from baseline to week 52 of
chronological age
structural outcomes at week 52 of chronological age, as determined by the Investigator. For
patients with both eyes enrolled in the study, both eyes must meet the endpoint.
Unfavorable structural outcomes are defined as retinal detachment, macular dragging, macular
fold, or retrolental opacity.
The secondary endpoints are:
• Proportion of patients requiring intervention with a second treatment modality from
baseline to week 52 of chronological age
• Proportion of patients with recurrence of ROP through week 52 of chronological age
• The proportion of patients with treatment-emergent adverse events (TEAEs) and
serious adverse events (SAEs) (ocular and systemic) from baseline to week 52 of
chronological age
Inclution Criteria
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.
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 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.
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
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
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
The Estimated Number of Participants
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Taiwan
3 participants
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Global
112 participants
