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Study to Assess the Efficacy,...

Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Last Updated: 2023-07-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2022-08-18

Brief Summary

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The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

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Detailed Description

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Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open-Label

Study Groups

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Aflibercept Group

Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline.

Group Type EXPERIMENTAL

aflibercept

Intervention Type DRUG

Administered IVT

Laser Group

Patients will undergo laser treatment in each eligible eye at baseline.

Group Type EXPERIMENTAL

laser photocoagulation

Intervention Type PROCEDURE

Transpupillary conventional laser will be administered according to standard local procedures.

Interventions

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aflibercept

Administered IVT

Intervention Type DRUG

laser photocoagulation

Transpupillary conventional laser will be administered according to standard local procedures.

Intervention Type PROCEDURE

Other Intervention Names

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EYLEA® REGN3 VEGF trap-eye BAY86-5321

Eligibility Criteria

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Inclusion Criteria

* Gestational age at birth ≤ 32 weeks or birth weight ≤1500 g
* Patients with treatment-naïve retinopathy of prematurity (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)

Exclusion Criteria

* Known or suspected chromosomal abnormality, genetic disorder, or syndrome
* Previous exposure to any Intravitreal (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 neonatal intensive care unit 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 stage 4 and stage 5)
* ROP involving only Zone III

Eligible Sex

ALL

Accepts Healthy Volunteers