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

NCT00485836 | Completed Phase 3 Results

• 1 other identifier: FVF4166g
• Study Type: interventional
• Target: 392
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Macular Edema; Retinal Vein Occlusion

Keywords

CRVO; RVO; Lucentis; Edema

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 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.

  Baseline and 6 months

Secondary Outcomes (6)

• Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline

  Baseline and 6 months

• Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline

  Baseline and 6 months

• Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6

  6 months

• Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6

  Baseline and 6 months

• Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6

  Baseline and 6 months

Study Arms (3)

Sham injection

SHAM COMPARATOR

Drug: Sham injection

Ranibizumab injection 0.3 mg

EXPERIMENTAL

Drug: Ranibizumab injection 0.3 mg

Ranibizumab injection 0.5 mg

EXPERIMENTAL

Drug: Ranibizumab injection 0.5 mg

Interventions

Sham injection DRUG

Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.

Also known as: Lucentis

Sham injection

Ranibizumab injection 0.3 mg DRUG

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.

Ranibizumab injection 0.3 mg

Ranibizumab injection 0.5 mg DRUG

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.

Also known as: Lucentis

Ranibizumab injection 0.5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Related Publications (2)

• Suner IJ, Bressler NM, Varma R, Lee P, Dolan CM, Ward J, Colman S, Rubio RG. Reading speed improvements in retinal vein occlusion after ranibizumab treatment. JAMA Ophthalmol. 2013 Jul;131(7):851-6. doi: 10.1001/jamaophthalmol.2013.114.

  PMID: 23699977 DERIVED

• Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.

  PMID: 23415775 DERIVED

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion; Edema

Interventions

salicylhydroxamic acid; Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Roman Rubio, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 28, 2017
• Results First Posted: February 25, 2011

Record last verified: 2017-06