Open-label, Randomized, Two-Arm, Controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal (IVT) Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (ROP)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04004208Tipo: INTERVENTIONALInicio: 25 de sept de 2019Fin estimado: 12 de feb de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

Elegibilidad

Edad máxima: 32 WeeksSexo: ALL

Criterios de inclusión

Gestational age at birth ≤ 32 weeks or birth weight ≤ 1500 g
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
Aggressive posterior retinopathy of prematurity (AP-ROP)
Weight at baseline (day of treatment) ≥ 800 g
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.

Criterios de exclusión

Known or suspected chromosomal abnormality, genetic disorder or syndrome
Previous exposure to any IVT or systemic anti-vascular endothelial growth factor (VEGF) agent, including maternal exposure during pregnancy and/or during breastfeeding
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)
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
Presence of active ocular infection within 5 days of the first treatment
Advanced stages of ROP with partial or complete retinal detachment (ROP Stages 4 and 5)
ROP involving only Zone III
Ocular abnormalities that may interfere with the administration of study intervention or assessment of the study primary endpoint
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
Previous surgical or nonsurgical treatment for ROP (IVT anti-VEGF injection, ablative laser therapy, cryotherapy, and vitrectomy)
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

Intervenciones

drug

Eylea (Aflibercept, BAY86-5321)

Solution in a sterile glass vial, Dose A, IVT injection.

procedure

Laser photocoagulation

Transpupillary conventional laser ablative therapy

Ubicaciones

Many Locations

Multiple Locations, Argentina

Hospital Público Descentralizado "Dr. Guillermo Rawson"

San Juan, Argentina

Patrocinadores

PrincipalBayer

ColaboradorRegeneron Pharmaceuticals

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Open-label, Randomized, Two-Arm, Controlled Study to Asse... | EligiMed