Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next)

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-Interventional: No study treatment will be administered in this study

Study summary

Primary objectives of the study are:

* To evaluate binocular visual acuity at the end of this study in patients included from the VGFTe-ROP-1920 study, for treatment of Retinopathy of Prematurity (ROP).
* To evaluate long-term safety outcomes in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.

Secondary objectives of the study are:

* To describe visual function in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.
* To describe overall development in patients included from the VGFTe-ROP-1920 study, for treatment of ROP.

Eligibility

Primary outcome measure(s)

• Binocular best-corrected visual acuity (BCVA) — 5 years of chronological age
• Proportion of Patients with Adverse Events — Up to 5 years of chronological age
• Proportion of Patients with Serious Adverse Events — Up to 5 years of chronological age

Trial sites (30)