This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
Treatment administered in 20090. Transpupillary conventional laser ablative therapy
Binocular best-corrected visual acuity in Snellen equivalent
Time frame: At 5 years of age.
Proportion of subjects with ocular AEs and SAEs
AE: adverse event SAE: serious adverse event
Time frame: Up to 5 years of age.
Proportion of subjects with systemic AEs and SAEs
Time frame: Up to 5 years of age.
Proportion of subjects developing unfavorable ocular structural outcome
Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity
Time frame: At 1,3 and 5 years of age.
Proportion of subjects with absence of active ROP and unfavorable structural outcomes
Time frame: At 1 year of age.
Best-corrected visual acuity in each eye
Time frame: At 3 and 5 years of age.
Refractive spherical equivalent in each eye
Time frame: At 3 and 5 years of age
Neurodevelopmental outcomes using BSID-III
BSID-III: The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a standard series of tests that will assess the development of children in 3 areas: cognition, language, and motor skills. It is recommended to be assessed at screening, 1 year and 2 years of age. The assessment at 2 years of age is mandatory.
Time frame: At 2 years of age
Neurodevelopmental outcomes using WPPSI-IV
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Hospital Público Descentralizado "Dr. Guillermo Rawson"
San Juan, Argentina
AZ Sint Jan Brugge - Ophthalmology
Bruges, Belgium
Hospital das Clínicas de Botucatu - UNESP Botucatu
Botucatu, São Paulo, Brazil
Unifesp/Epm
São Paulo, Brazil
UMHAT Sveti Georgi
Plovdiv, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, Bulgaria
Spec. Hospital of Ophthalm. for Active Treatment Visus
Sofia, Bulgaria
Spec. Hosp. of Ophthalm. Disease for Active Treatment Varna
Varna, Bulgaria
Fakultní nemocnice Ostrava
Ostrava, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
...and 45 more locations
WPPSI-IV: The Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition is designed to assess development of older children and is recommended to be performed at 3, 4 and 5 years of age. The assessment at 5 years of age is mandatory. In cases where the WPSSI-IV cannot be used, the Differential Ability Scales II (DAS-II) may be used as an alternative.
Time frame: At 5 years of age
Neurodevelopmental outcomes using VABS-II
VABS-II: Vineland Adaptive Behavior Scales, Second Edition Expanded Interview will be included, which includes 4 areas: Communication, Daily Living skills, Socialization and Motor Skills. It is recommended to be assessed at 2, 3, 4 and 5 years of age. The assessments at 2 years and 5 years of age are mandatory.
Time frame: At 2 and 5 years of age
Proportion of subjects with recurrence of ROP
Time frame: At 3 and 5 years of age.
Proportion of subjects requiring treatment for ROP
Time frame: Up to 5 years of age.
Proportion of subjects requiring ophthalmological treatment
Time frame: Up to 5 years of age.