Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007235

Trial Description

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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)

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Trial Acronym

CARE-ROP

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007235
  •   2015/05/05
  •   2014/04/26
  •   yes
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Secondary IDs

  •   2013-002539-13 
  •   NCT02134457  (ClinicalTrials.gov)
  •   CARE-ROP  (University Hospital Freiburg)
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Health Condition or Problem studied

  •   Retinopathy of Prematurity (ROP)
  •   H35.1 -  Retinopathy of prematurity
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Interventions/Observational Groups

  •   Biological: ranibizumab
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
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  •   Treatment
  •   Parallel
  •   II
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Primary Outcome

- 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.

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/08/31
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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).

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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.

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Addresses

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    • University Hospital Freiburg
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    • University Eye Hospital Freiburg, Germany
    • Andreas Stahl, MD 
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    • University Eye Hospital Freiburg, Germany
    • Andreas Stahl, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2017/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2017/04/24
* This entry means the parameter is not applicable or has not been set.