Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-01-31

Brief Summary

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This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates.

The primary objective is to assess clinical efficacy of ranibizumab in children with ROP

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Detailed Description

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Conditions

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Retinopathy of Prematurity (ROP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ranibizumab 0.12 mg

20 µl of the 6 mg/ml ranibizumab concentration will be applied intravitreally. After an initial response the same dose as in the first injection can be re-applied after at least four weeks post injection.

A maximum number of 3 regular re-injections can be applied.

Group Type EXPERIMENTAL

ranibizumab

Intervention Type BIOLOGICAL

Ranibizumab 0.20 mg

20 µl of the 10 mg/ml ranibizumab concentration will be applied intravitreally. After an initial response the same dose as in the first injection can be re-applied after at least four weeks post injection.

A maximum number of 3 re-injections can be applied.

Group Type EXPERIMENTAL

ranibizumab

Intervention Type BIOLOGICAL

Interventions

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ranibizumab

Intervention Type BIOLOGICAL

Other Intervention Names

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Lucentis

Eligibility Criteria

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Inclusion Criteria

* Bilateral ROP in zone I (stage 1+, 2+, 3+/-, AP-ROP) or ROP in central (=posterior) zone II (stage 3+, AP-ROP). Zone I is defined as twice the distance from the optic disc to the fovea measured temporally, posterior zone II is defined as three times the distance from the optic disc to the fovea measured temporally.
* Legal representatives or their designates willing and able to attend regular study visits with the study infant.
* Written informed consent to participate in the study (signed by all patient's legal representatives).

Exclusion Criteria

* Pediatric conditions rendering the infant ineligible to anti-VEGF treatment or to repeated blood draws as evaluated by a neonatal ICU specialist and a study ophthalmologist.
* Congenital brain lesions significantly impairing optic nerve function.
* Severe hydrocephalus with significantly increased intracranial pressure.
* Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and 5).
* ROP involving only the peripheral retina (i.e. peripheral zone II or zone III).
* Known hypersensitivity to the study drug or to drugs with similar chemical structures.
* Contraindications for an intravitreal injection as listed in ranibizumab SmPC.
* Systemic use of anti-VEGF therapeutics.
* Use of other investigational drugs - excluding vitamins and minerals - at the time of enrollment, or within 30 days or 5 half-lives prior to enrollment, whichever is longer.

Eligible Sex

ALL

Accepts Healthy Volunteers

No