An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513231-24-00

Acronym

VGFTe-ROP-2036

Enrollment

Registered

2024-10-04

Start date

2022-03-22

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of prematurity (ROP)

Brief summary

Binocular best-corrected visual acuity (BCVA), Proportion of Patients with Adverse Events, Proportion of Patients with Serious Adverse Events

Detailed description

Proportion of patients developing unfavorable ocular structural outcome, BCVA in each eye, Refractive spherical equivalent in each eye, Neurodevelopmental outcomes using BSID-III, Neurodevelopmental outcomes using WPPSI-IV, Neurodevelopmental outcomes using VABS-II, Proportion of patients with recurrence of ROP, Proportion of patients requiring treatment for ROP

Interventions

DRUGEylea 40 mg/mL solution for injection in a vial

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Binocular best-corrected visual acuity (BCVA), Proportion of Patients with Adverse Events, Proportion of Patients with Serious Adverse Events	—

Secondary

Measure	Time frame
Proportion of patients developing unfavorable ocular structural outcome, BCVA in each eye, Refractive spherical equivalent in each eye, Neurodevelopmental outcomes using BSID-III, Neurodevelopmental outcomes using WPPSI-IV, Neurodevelopmental outcomes using VABS-II, Proportion of patients with recurrence of ROP, Proportion of patients requiring treatment for ROP	—

Countries

Bulgaria, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026