Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

Last updated: September 21, 2016
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Macular Edema

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT01535261
CRFB002E2401
2011-002350-31
  • Ages > 18
  • All Genders

Study Summary

The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age

  • Diagnosis of visual impairment exclusively due to ME secondary to CRVO

  • BCVA score at Screening and Baseline between 73 and 19 letters Early TreatmentDiabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalentof 20/40 and 20/400)

Exclusion

Exclusion Criteria:

  • Uncontrolled blood pressure defined as systolic value of > 160 mm Hg or diastolicvalue of > 100 mm Hg at Screening or Baseline.

  • Any active periocular or ocular infection or inflammation at Screening or Baseline ineither eye

  • Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months beforeBaseline in either eye

  • Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])

Study Design

Total Participants: 357
Study Start date:
February 01, 2012
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • Novartis Investigative Site

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Novartis Investigative Site

    Sydney, New South Wales 2000
    Australia

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    Melbourne, Victoria 3002
    Australia

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    Nedlands, Western Australia 6009
    Australia

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    East Melbourne,
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    Perth,
    Australia

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    Linz, 4021
    Austria

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    Wien, 1090
    Austria

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    Calgary, Alberta T2H0C8
    Canada

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    Vancouver, British Columbia V5Z 1M9
    Canada

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    Victoria, British Columbia V8V 4X3
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    Halifax, Nova Scotia B3H 2Y9
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    London, Ontario N6A 4G5
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    Boisbriand, Quebec J7H 1S6
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