Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP)

March 8, 2017 updated by: Andreas Stahl, MD, University Hospital Freiburg

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • University Eye Hospital
      • Duesseldorf, Germany, 40225
        • University Eye Hospital
      • Kiel, Germany, 24105
        • University Eye Hospital
      • Magdeburg, Germany, 39120
        • University Eye Hospital
      • Muenster, Germany, 48149
        • University Eye Hospital
      • Munich, Germany, 80336
        • University Eye Hospital
      • Regensburg, Germany, 93053
        • University Eye Hospital
      • Tuebingen, Germany, 72076
        • University Eye Hospital
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: ranibizumab
Other Names:
  • Lucentis
Experimental: 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.
Biological: ranibizumab
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of treatment
Time Frame: Up to 24 weeks post first injection

Efficacy is determined by the number of infants without need for rescue treatment up to week 24 post first injection.

Re-injection of study dose is not considered rescue treatment if applied after an initial response to treatment and after at least 4 weeks post injection.
Up to 24 weeks post first injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Regression of plus disease
Time Frame: Up to 24 weeks post first injection
Up to 24 weeks post first injection
Regression of preretinal vascularized ridge
Time Frame: Up to 24 weeks post first injection
Up to 24 weeks post first injection
Progression of peripheral intraretinal vascularization beyond ridge
Time Frame: Up to 24 weeks post first injection
Up to 24 weeks post first injection
Number and kind of AEs and SAEs
Time Frame: Up to 24 weeks post first injection
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
Up to 24 weeks post first injection
Number of re-injections of study dose
Time Frame: Up to 24 weeks post first injection
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
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
Up to 24 weeks post first injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of late recurrences of ROP during the follow-up period
Time Frame: Up to 5 years post first injection
Up to 5 years post first injection
Number of patients progressing to stage 4 or 5 ROP after the core study
Time Frame: Up to 5 years post first injection
Up to 5 years post first injection
Number of patients with complete vascularization of the peripheral retina to within one disc diameter of the ora serrata after the end of the core study
Time Frame: Up to 5 years post first injection
Up to 5 years post first injection
Long-term ophthalmological development: visual acuity (if possible), orthoptic status, cycloplegic retinoscopy, refraction, IOP, fundoscopy including fundus photographs
Time Frame: Up to 5 years post first injection
At one year and at 5 years an ophthalmological visit will take place.
Up to 5 years post first injection
Long-term pediatric development: Bayley-test, weight, height, cognitive, motor and sensory development
Time Frame: Up to 5 years post first injection
Up to 5 years post first injection
Number and kind of AEs or SAEs per group between the end of the observational core study and the end of the follow-up period
Time Frame: Up to 5 years post first injection
Up to 5 years post first injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

April 26, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARE-ROP
  • 2013-002539-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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