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 (VGFTe-ROP-1920)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Retinopathy Of Prematurity
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Age: Between 0 years - 5 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Signed informed consent from parent(s)/legally authorized representative(s)
- Participants whose weight at baseline (day of treatment) =800 g
- Participants who have gestational age at birth =32 weeks or birth weight =1500 g
- Participants with treatment-nai¨ve Retinopathy of Prematurity(ROP) classified according to the International Classification for ROP in at least one eye
You may not be eligible for this study if the following are true:
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- Participants with known or suspected chromosomal abnormality, genetic disorder, or syndrome
- Those previously exposed to any IVT or systemic anti-VEGF agent, including maternal exposure during pregnancy and/or during breastfeeding
- Participants with clinically significant neurological disease
- 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
- Participants with active ocular infection within 5 days of the first treatment
- Those with advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5)
- Retinopathy of Prematurity(ROP) involving only Zone III
- Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
- Participants who had 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
- Participants who previously had surgical or nonsurgical treatment for ROP
- Participants or the mother in other clinical trials requiring administration of investigational treatments
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.