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Trial record 24 of 293 for:    retinopathy of prematurity

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

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ClinicalTrials.gov Identifier: NCT02134457
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Andreas Stahl, MD, University Hospital Freiburg

Brief 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


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity (ROP) Biological: ranibizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : August 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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 Name: 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 Name: Lucentis




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Regression of plus disease [ Time Frame: Up to 24 weeks post first injection ]
  2. Regression of preretinal vascularized ridge [ Time Frame: Up to 24 weeks post first injection ]
  3. Progression of peripheral intraretinal vascularization beyond ridge [ Time Frame: Up to 24 weeks post first injection ]
  4. Number and kind of AEs and SAEs [ Time Frame: Up to 24 weeks post first injection ]
  5. Changes in vascular endothelial growth factor (VEGF) levels in the systemic circulation [ Time Frame: Up to 24 weeks post first injection ]
  6. Number of re-injections of study dose [ Time Frame: Up to 24 weeks post first injection ]
  7. Number of patients progressing to stage 4 or 5 ROP [ Time Frame: Up to 24 weeks post first injection ]
  8. 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 ]

Other Outcome Measures:
  1. Number of late recurrences of ROP during the follow-up period [ Time Frame: Up to 5 years post first injection ]
  2. Number of patients progressing to stage 4 or 5 ROP after the core study [ Time Frame: Up to 5 years post first injection ]
  3. 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 ]
  4. 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.

  5. Long-term pediatric development: Bayley-test, weight, height, cognitive, motor and sensory development [ Time Frame: Up to 5 years post first injection ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134457


Locations
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Germany
University Eye Hospital
Freiburg, Baden-Wuerttemberg, Germany, 79106
University Eye Hospital
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
Sponsors and Collaborators
University Hospital Freiburg
Investigators
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Principal Investigator: Andreas Stahl, MD University Eye Hospital Freiburg, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andreas Stahl, MD, MD, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT02134457     History of Changes
Other Study ID Numbers: CARE-ROP
2013-002539-13 ( EudraCT Number )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents