Overview

This trial is active, not recruiting.

Condition retinopathy of prematurity (rop)
Treatment ranibizumab
Phase phase 2
Target VEGF
Sponsor University Hospital Freiburg
Start date August 2014
End date January 2017
Trial size 19 participants
Trial identifier NCT02134457, 2013-002539-13, CARE-ROP

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
ranibizumab Lucentis
(Experimental)
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.
ranibizumab Lucentis

Primary Outcomes

Measure
Efficacy of treatment
time frame: Up to 24 weeks post first injection

Secondary Outcomes

Measure
Regression of plus disease
time frame: Up to 24 weeks post first injection
Regression of preretinal vascularized ridge
time frame: Up to 24 weeks post first injection
Progression of peripheral intraretinal vascularization beyond ridge
time frame: Up to 24 weeks post first injection
Number and kind of AEs and SAEs
time frame: Up to 24 weeks post first injection
Changes in vascular endothelial growth factor (VEGF) levels in the systemic circulation
time frame: Up to 24 weeks post first injection
Number of re-injections of study dose
time frame: Up to 24 weeks post first injection
Number of patients progressing to stage 4 or 5 ROP
time frame: Up to 24 weeks post first injection
Number of patients with complete vascularization of the peripheral retina to within one disc diameter of the ora serrata
time frame: Up to 24 weeks post first injection

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Multicenter Randomized Double Masked Parallel Design Exploratory Study to Assess Safety and Efficacy of Two Different Doses of Intravitreal Anti-VEGF Treatment With Ranibizumab (0.12 mg vs. 0.20 mg) in Infants With Retinopathy of Prematurity (ROP)
Principal investigator Andreas Stahl, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospital Freiburg.