Clinical Trials List
Protocol NumberBAY 86-5321 / 20090
2019-09-25 - 2021-02-12
Phase III
Terminated3
ICD-10H35.89
Other specified retinal disorders
ICD-9362.89
Other retinal disorders
Open-label, randomized, two–arm, controlled study to assess the efficacy, safety, and tolerability of intravitreal (IVT) aflibercept compared to laser photocoagulation in patients with retinopathy of prematurity (ROP)
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
Bayer AG.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hsiu-Lin Chen Division of Ophthalmology
- Li-chung Chi Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Retinopathy of Prematurity
Objectives
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy.
The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Test Drug
Eylea
Active Ingredient
aflibercept
Dosage Form
Dosage
0.4 mg/0.01 mL
Endpoints
Primary Outcome Measures :
Proportion of patients with absence of active ROP and unfavorable structural outcomes [ Time Frame: At 24 weeks after starting study treatment ]
Secondary Outcome Measures :
Number of requirement for intervention with a second treatment modality [ Time Frame: From baseline to Week 24 ]
Recurrence of ROP [ Time Frame: From baseline to Week 24 ]
To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium [ Time Frame: From baseline to Week 24 ]
Number of aflibercept administrations [ Time Frame: From baseline to Week 24 ]
Number of laser treatments [ Time Frame: From baseline to Week 24 ]
Proportion of participants with ocular TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
TEAE: treatment-emergent adverse event SAE: serious adverse event
Proportion of participants with systemic TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling [ Time Frame: From baseline to Week 24 ]
Presence of anti-drug antibodies [ Time Frame: Before and 12 weeks after aflibercept injection ]
Proportion of patients with absence of active ROP and unfavorable structural outcomes [ Time Frame: At 24 weeks after starting study treatment ]
Secondary Outcome Measures :
Number of requirement for intervention with a second treatment modality [ Time Frame: From baseline to Week 24 ]
Recurrence of ROP [ Time Frame: From baseline to Week 24 ]
To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium [ Time Frame: From baseline to Week 24 ]
Number of aflibercept administrations [ Time Frame: From baseline to Week 24 ]
Number of laser treatments [ Time Frame: From baseline to Week 24 ]
Proportion of participants with ocular TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
TEAE: treatment-emergent adverse event SAE: serious adverse event
Proportion of participants with systemic TEAEs and SAEs [ Time Frame: From baseline to Week 24 ]
Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling [ Time Frame: From baseline to Week 24 ]
Presence of anti-drug antibodies [ Time Frame: Before and 12 weeks after aflibercept injection ]
Inclution Criteria
Inclusion Criteria:
1. Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
2. Subjects 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
Aggressive posterior retinopathy of prematurity (AP-ROP)
3. Weight at baseline (day of treatment) ≥ 800 g
4. Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
1. Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
2. Subjects 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
Aggressive posterior retinopathy of prematurity (AP-ROP)
3. Weight at baseline (day of treatment) ≥ 800 g
4. Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
Known or suspected chromosomal abnormality, genetic disorder or syndrome
Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
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)
Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist
Presence of active ocular infection within 5 days of the first treatment
Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
ROP involving only Zone III
Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
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
Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
Participation of the subject 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
Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
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)
Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist
Presence of active ocular infection within 5 days of the first treatment
Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
ROP involving only Zone III
Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
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
Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
Participation of the subject 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
121 participants
