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Trial record 1 of 13 for:    CRUISE
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A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE) (CRUISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00485836
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : February 25, 2011
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE June 11, 2007
First Posted Date  ICMJE June 13, 2007
Results First Submitted Date  ICMJE August 16, 2010
Results First Posted Date  ICMJE February 25, 2011
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE July 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months [ Time Frame: Baseline and 6 months ]
BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2007)
The primary efficacy outcome measure is the mean change from baseline in BCVA score at 6 months
Change History Complete list of historical versions of study NCT00485836 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
  • Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline [ Time Frame: Baseline and 6 months ]
    BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
  • Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline [ Time Frame: Baseline and 6 months ]
    BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
  • Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6 [ Time Frame: 6 months ]
    A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.
  • Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6 [ Time Frame: Baseline and 6 months ]
    A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.
  • Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6 [ Time Frame: Baseline and 6 months ]
    The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
  • Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6 [ Time Frame: Baseline and 6 months ]
    The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2007)
  • Proportion of subjects who gain at least 15 letters in BCVA score at 6 months compared with baseline
  • Proportion of subjects who lose fewer than 15 letters in BCVA score at 6 months compared with baseline
  • Mean change from baseline in BCVA score over time up to 6 months
  • Proportion of subjects with a central foveal thickness of ≤ 250 μm, assessed by OCT, at 6 months
  • Mean absolute change from baseline in central foveal thickness, assessed by OCT, over time up to 6 months
  • Mean change from baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) near activities subscale over time up to 6 months
  • Mean change from baseline in the NEI VFQ-25 distance activities subscale over time up to 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion
Brief Summary This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to central retinal vein occlusion (CRVO); 392 patients with CRVO were enrolled at 95 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Retinal Vein Occlusion
Intervention  ICMJE
  • Drug: Sham injection
    Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
    Other Name: Lucentis
  • Drug: Ranibizumab injection 0.3 mg
    Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
  • Drug: Ranibizumab injection 0.5 mg
    Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
    Other Name: Lucentis
Study Arms  ICMJE
  • Sham Comparator: Sham injection
    Intervention: Drug: Sham injection
  • Experimental: Ranibizumab injection 0.3 mg
    Intervention: Drug: Ranibizumab injection 0.3 mg
  • Experimental: Ranibizumab injection 0.5 mg
    Intervention: Drug: Ranibizumab injection 0.5 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2010)
392
Original Enrollment  ICMJE
 (submitted: June 11, 2007)
390
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willingness to provide signed Informed Consent Form
  • Age ≥ 18 years
  • For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
  • Ability and willingness to return for all scheduled visits and assessments

Ocular Inclusion Criterion (Study Eye):

  • Foveal center-involved macular edema secondary to CRVO
  • BCVA using ETDRS charts of 20/40 to 20/320 (Snellen equivalent)
  • Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at screening [confirmed by the central reading center] and Day 0 [confirmed by the evaluating physician])
  • Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus photographs

Exclusion Criteria:

  • History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
  • History of any anti-vascular endothelial growth factor (VEGF) or treatment in the fellow eye within 3 months prior to Day 0
  • History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
  • History of allergy to fluorescein
  • History of allergy to ranibizumab injection or related molecule
  • Relevant systemic disease that may be associated with increased systemic VEGF levels (namely, all active malignancies); history of successfully treated malignancies is not an exclusion criterion.
  • Uncontrolled blood pressure
  • Pregnancy or lactation
  • Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term follow-up, and likelihood of survival of less than 1 year)
  • Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug (excluding vitamins and minerals) or device that has not received regulatory approval at time of study entry

Ocular Exclusion Criteria (Study Eye):

  • Prior episode of retinal vein occlusion (RVO)
  • Brisk afferent pupillary defect
  • History of radial optic neurotomy or sheathotomy
  • History or presence of age-related macular degeneration (AMD; dry or wet form)
  • History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0
  • History of laser photocoagulation for macular edema within 4 months prior to Day 0
  • History of panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 4 months following randomization
  • History of intraocular corticosteroid use within 3 months prior to Day 0
  • History of pars plana vitrectomy
  • History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0
  • History of yttrium-aluminum-garnet capsulotomy performed within 2 months prior to Day 0
  • Previous filtration surgery in the study eye
  • History of herpetic ocular infection
  • History of ocular toxoplasmosis
  • History of rhegmatogenous retinal detachment
  • History of idiopathic central serous chorioretinopathy
  • Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
  • An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
  • Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
  • Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity
  • Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract)
  • Aphakia
  • Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)
  • Improvement of > 10 letters on best corrected visual acuity (BCVA) between screening and Day 0
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00485836
Other Study ID Numbers  ICMJE FVF4166g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roman Rubio, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP