Retinopathy of prematurity MedDRA version: 20.1 Level: PT Classification code 10038933 Term: Retinopathy of prematurity System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Gestational age at birth = 32 weeks or birth weight = 1500 g Type of Participant and Disease Characteristics 2.Subjects with treatment-naïve ROP classified according to the International Classification for ROP in at least one eye as: - Zone I Stage 1 plus, or 2 plus, or 3 non-plus or 3 plus, or Zone II Stage 2 plus or 3 plus, or AP-ROP 3.Weight at baseline (day of treatment) = 800 g 4.Male or female 5.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 clinical trial protocol Are the trial subjects under 18? yes Number of subjects for this age range: 135 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 any of the following “per subject” criteria are met. A potential study eye is excluded from the study if any of the “per eye” criteria are met: Medical Conditions – per subject 1.Known or suspected chromosomal abnormality, genetic disorder or syndrome 2.Previous exposure to any IVT or systemic anti-VEGF agent, including maternal exposure during pregnancy and/or during breastfeeding 3.Clinically significant neurological disease (eg, intraventricular hemorrhage grade 3 or higher, periventricular leukomalacia, congenital brain lesions significantly impairing optic nerve function, severe hydrocephalus with significantly increased intracranial pressure) 4.Pediatric conditions rendering the infant ineligible for study intervention at baseline or for repeated blood draws as evaluated by a NICU specialist and a study ophthalmologist 5.Presence of active ocular infection within 5 days of the first treatment Medical Conditions – per eye 6.Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5) 7.ROP involving only Zone III 8.Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint Prior/Concomitant Therapy – per subject 9.Postnatal treatment with oral or intravenous corticosteroids at an equivalent dose of prednisone = 1 mg/kg/day for > 2 weeks within 14 days of the first study intervention Prior/Concomitant Therapy – per eye 10.Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy) Prior/Concurrent Clinical Study Experience 11.Participation of the subject or the mother in other clinical trials requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening, or within 30 days or 5 half-lives of administration of the previous study drug, whichever is longer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of aflibercept in subjects diagnosed with retinopathy of prematurity (ROP) in comparison to laser;Secondary Objective: To assess the safety and tolerability of aflibercept To assess the treatment burden of aflibercept and laser To describe the systemic exposure to aflibercept ;Primary end point(s): Primary Endpoint Proportion of patients with absence of active ROP and unfavorable structural outcomes at 24 weeks after starting study treatment ;Timepoint(s) of evaluation of this end point: at 24 weeks after starting study Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • From baseline to Week 24 ;Secondary end point(s): Secondary Endpoints addressing primary objectives Requirement for intervention with a second treatment modality from baseline to Week 24 Recurrence of ROP from baseline to Week 24 To explore new Retinopathy of Prematurity Activity Scale proposed by the International Neonatal Consortium Secondary Endpoints addressing secondary objectives •Number of aflibercept administrations from baseline to Week 24 •Number of laser treatments from baseline to Week 24 •Proportion of participants with ocular TEAEs and SAEs from baseline to Week 24 •Proportion of participants with systemic TEAEs and SAEs from baseline to Week 24 •Systemic exposure to free aflibercept (at expected maximum plasma concentration and during elimination period from plasma) determined by sparse sampling •Presence of anti-drug antibodies before and 12 weeks after aflibercept injection | — |
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