Retinopathy of Prematurity (ROP)
Conditions
Brief summary
This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.
Interventions
Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
PROCEDURELaser photocoagulation
Treatment administered in 20090. Transpupillary conventional laser ablative therapy
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 13 Months
Healthy volunteers
No
Inclusion criteria
* Subject was treated in Study 20090 * Age less than 13 months of chronological age * Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion criteria
\- Subject has a condition preventing participation in the study, or performance of study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular best-corrected visual acuity in Snellen equivalent | At 5 years of age. | — |
| Proportion of subjects with ocular AEs and SAEs | Up to 5 years of age. | AE: adverse event SAE: serious adverse event |
| Proportion of subjects with systemic AEs and SAEs | Up to 5 years of age. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Refractive spherical equivalent in each eye | At 3 and 5 years of age | — |
| Neurodevelopmental outcomes using BSID-III | At 2 years of age | 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. |
| Neurodevelopmental outcomes using WPPSI-IV | At 5 years of age | 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. |
| Proportion of subjects developing unfavorable ocular structural outcome | At 1,3 and 5 years of age. | Unfavorable ocular structural outcome include: retinal detachment, macular dragging, macular fold, retrolental opacity |
| Proportion of subjects with recurrence of ROP | At 3 and 5 years of age. | — |
| Proportion of subjects requiring treatment for ROP | Up to 5 years of age. | — |
| Proportion of subjects requiring ophthalmological treatment | Up to 5 years of age. | — |
| Neurodevelopmental outcomes using VABS-II | At 2 and 5 years of age | 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. |
| Proportion of subjects with absence of active ROP and unfavorable structural outcomes | At 1 year of age. | — |
| Best-corrected visual acuity in each eye | At 3 and 5 years of age. | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Czechia, Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Portugal, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Outcome results
None listed