Retinopathy of prematurity MedDRA version: 20.1 Level: PT Classification code 10038933 Term: Retinopathy of prematurity System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: No therapeutic treatment is administered in the context of this investigation, however subjects have previously received Aflibercept 40mg/ml in the context of study 20090.
Product Name: Af
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if both of the following criteria apply: 1.Subject was treated in Study 20090 2.Age less than 13 months of chronological age 3.Signed informed consent from parent(s)/legally authorized representative(s) as described in Section 10.1.3 of the clinical trial protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol Are the trial subjects under 18? yes Number of subjects for this age range: 102 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if the following criterion applies: Medical Conditions 1. Subject has a condition preventing participation in the study, or performance of study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate long-term safety outcomes and visual function of subjects included in study 20090 for treatment for retinopathy of prematurity (ROP) ;Secondary Objective: To describe the visual function and overall development of subjects included in study 20090 for treatment for ROP ;Primary end point(s): • Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age;Timepoint(s) of evaluation of this end point: at 5 years of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints addressing primary objective: •Proportion of subjects with ocular adverse events (AEs) and serious AEs (SAEs) through 5 years of age •Proportion of subjects with systemic AEs and SAEs through 5 years of age Secondary endpoints addressing secondary objectives: •Proportion of subjects developing unfavorable ocular structural outcome (retinal detachment, macular dragging, macular fold, retrolental opacity) at 1, 3, and 5 years of age •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 •Refractive spherical equivalent in each eye at 3 and 5 years of age •Neurodevelopmental outcomes at 2 and 5 years of age using standardized development tests (eg. Bayley Scales of Infant and Toddler Development, Third Edition [BSID-III], the Differential Ability Scales® II [DAS-II®], the Wechsler Preschool and Primary Scale of Intelligence™, Fourth Edition [WPPSI-IV], Vineland Behaviour Scales, Second Edition [VABS-II]). •Proportion of subjects with recurrence of ROP at 3 and 5 years of age •Proportion of subjects requiring treatment for ROP during this extension study •Proportion of subjects requiring ophthalmological treatment during this extension study;Timepoint(s) of evaluation of this end point: through 5 years of age | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Democratic People's Republic of, Latvia, Lithuania, Malaysia, Netherlands, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed