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OpenTrials
Completed

NCT Number: NCT01377597

Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
  • Best-corrected visual acuity (BCVA):
  • CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
  • BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2

Exclusion criteria

  • Pregnant or nursing women
  • History of stroke
  • Uncontrolled blood pressure
  • Active ocular infection or intraocular inflammation in either eye
  • Uncontrolled glaucoma in either eye
  • Neovascularization of the iris or neovascular glaucoma in either eye
  • Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
  • Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
  • Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
  • Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
  • Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
  • Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
  • Use of any intra-ocular corticosteroid implants in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

ranibizumab

Drug

Primary outcomes

  1. Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline

    Time frame: 3 months

Secondary outcomes

  1. Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit

    Time frame: 3 months

  2. Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3

    Time frame: 3 months

  3. Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3

    Time frame: 3 months

  4. Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3

    Time frame: 3 months

  5. Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)

Acronym: RVO in Japan

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 21, 2011
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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