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Clinical Trials/EUCTR2011-002350-31-DK
EUCTR2011-002350-31-DK
Active, not recruiting
Not Applicable

A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven PRN dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) - CRYSTA

ovartis Pharma Services AG0 sites350 target enrollmentStarted: March 21, 2012Last updated:
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Conditionsvisual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)MedDRA version: 14.1Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsLUCENTIS

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
350
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •\- Written informed consent must be obtained before any study assessment is performed\- Male or female patients must be at least 18 years of age
  • •\- Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein occlusion (CRVO)
  • •\- Best\-corrected visual acuity at Screening and Baseline must be between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400\)
  • •Other protocol\-defined inclusion criteria may apply
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
  • •Stroke or myocardial infarction less than 3 months prior to Screening
  • •Uncontrolled blood pressure defined as systolic value of \>160 mm Hg or diastolic value of \>100 mm Hg at Screening or Baseline. Antihypertensive treatment can be initiated and has to be taken for at least 30 days after which the patient can be assessed for study eligibility a second time
  • •Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
  • •Uncontrolled glaucoma (intraocular pressure \[IOP] \=30 mm Hg on medication or according to investigator’s judgment) at Screening or Baseline or diagnosed within 6 months prior to Baseline in either eye
  • •Neovascularization of the iris or neovascular glaucoma in either eye
  • •Use of any systemic anti\-vascular endothelial growth factor (VEGF) drugs within 6 months prior to Baseline (eg, sorafenib \[Nexavar®], sunitinib \[Sutent®], bevacizumab \[Avastin®])
  • •Prior treatment with any anti\-angiogenic drugs (including any anti\-VEGF agents) within 3 months prior to Baseline in either eye (eg, pegaptanib \[Macugen®], ranibizumab \[Lucentis®], bevacizumab \[Avastin®])
  • •Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
  • •Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye

Investigators

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