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:

  • Conditions:
    Retinopathy Of Prematurity
  • Age: Between 0 - 5 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Signed informed consent from parent(s)/legally authorized representative(s)
    2. Participants whose weight at baseline (day of treatment) =800 g
    3. Participants who have gestational age at birth =32 weeks or birth weight =1500 g
    4. 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:

    1. Participants with known or suspected chromosomal abnormality, genetic disorder, or syndrome
    2. Those previously exposed to any IVT or systemic anti-VEGF agent, including maternal exposure during pregnancy and/or during breastfeeding
    3. Participants with clinically significant neurological disease
    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. Participants with active ocular infection within 5 days of the first treatment
    6. Those with advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and stage 5)
    7. Retinopathy of Prematurity(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. 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
    10. Participants who previously had surgical or nonsurgical treatment for ROP
    11. Participants or the mother in other clinical trials requiring administration of investigational treatments



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