A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00485836
First received: June 11, 2007
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

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).


Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
Drug: Sham injection
Drug: Ranibizumab injection 0.3 mg
Drug: Ranibizumab injection 0.5 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 392
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham injection 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
Experimental: Ranibizumab injection 0.3 mg 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.
Experimental: Ranibizumab injection 0.5 mg 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00485836

Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Roman Rubio, M.D. Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00485836     History of Changes
Other Study ID Numbers: FVF4166g
Study First Received: June 11, 2007
Results First Received: August 16, 2010
Last Updated: February 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
CRVO
RVO
Lucentis
Edema

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on October 22, 2014