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

ClinicalTrials.gov Identifier:

NCT00485836

First received: June 11, 2007

Last updated: February 1, 2011

Last verified: February 2011

History of Changes

Results First Received: August 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Macular Edema Retinal Vein Occlusion
Interventions:	Drug: Sham injection Drug: Ranibizumab injection 0.3 mg Drug: Ranibizumab injection 0.5 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Please note that although the table below is titled "Overall Study," the completion rates are for the 6-month Treatment Period only (i.e., does not include the 6-month Observation Period data).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.
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.
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.

Participant Flow: Overall Study

	Sham Injection	Ranibizumab Injection 0.3 mg	Ranibizumab Injection 0.5 mg
STARTED	130	132	130
Received Study Drug (Safety Population)	129	132	129
COMPLETED	115	129	119
NOT COMPLETED	15	3	11

Baseline Characteristics

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Reporting Groups

	Description
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.
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Sham Injection	Ranibizumab Injection 0.3 mg	Ranibizumab Injection 0.5 mg	Total
Number of Participants [units: participants]	130	132	130	392
Age [units: years] Mean ± Standard Deviation	65.4 ± 13.1	69.7 ± 11.6	67.6 ± 12.4	67.6 ± 12.5
Age, Customized [units: participants]
< 45 years	10	5	5	20
45 to < 65 years	50	36	46	132
65 to < 85 years	67	80	71	218
≥ 85 years	3	11	8	22
Gender [units: participants]
Female	58	61	50	169
Male	72	71	80	223

Outcome Measures

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1. Primary:

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months [ Time Frame: Baseline and 6 months ]

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2. Secondary:

Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline [ Time Frame: Baseline and 6 months ]

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3. Secondary:

Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline [ Time Frame: Baseline and 6 months ]

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4. Secondary:

Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6 [ Time Frame: 6 months ]

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5. Secondary:

Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6 [ Time Frame: Baseline and 6 months ]

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6. Secondary:

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 ]

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7. Secondary:

Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6 [ Time Frame: Baseline and 6 months ]

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Serious Adverse Events

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Time Frame	6 months
Additional Description	Investigators assessed the occurrence of AE/SAEs at all study visits. Summaries are for the safety-evaluable population and include events regardless of relation to study drug or location (e.g. non-study eye events are included). For each AE/SAE, the number of patients experiencing the event, not the number of occurrences of the event, is reported.

Reporting Groups

	Description
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.
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.
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.

Serious Adverse Events

	Sham Injection	Ranibizumab Injection 0.3 mg	Ranibizumab Injection 0.5 mg
Total, serious adverse events
# participants affected / at risk	13/129 (10.08%)	16/132 (12.12%)	13/129 (10.08%)
Cardiac disorders
Cardiomyopathy ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Arteriosclerosis Coronary Artery ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Coronary Artery Disease ^{† 1}
# participants affected / at risk	2/129 (1.55%)	1/132 (0.76%)	1/129 (0.78%)
Cardiac Failure Congestive ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Acute Coronary Syndrome ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Angina Pectoris ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Myocardial Infarction ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	1/129 (0.78%)
Atrial Fibrillation ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Supraventricular Tachycardia ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Eye disorders
Blindness Unilateral ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Vitreous Hemorrhage ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Corneal Edema ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Iris Neovascularization ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Retinal Disorder ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Macular Ischemia ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Retinal Artery Occlusion ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Retinal Vascular Disorder ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Retinal Vascular Occlusion ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Retinal Vein Occlusion ^{† 1}
# participants affected / at risk	2/129 (1.55%)	1/132 (0.76%)	1/129 (0.78%)
Maculopathy ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Retinal Depigmentation ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Macular Edema ^{† 1}
# participants affected / at risk	2/129 (1.55%)	2/132 (1.52%)	0/129 (0.00%)
Gastrointestinal disorders
Colitis ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	1/129 (0.78%)
Umbilical Hernia ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
General disorders
Chest Pain ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Immune system disorders
Food Allergy ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Infections and infestations
Diverticulitis ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	1/129 (0.78%)
Cellulitis ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Bronchitis ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Injury, poisoning and procedural complications
Lead Dislodgement ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Hip Fracture ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Humerus Fracture ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Metabolism and nutrition disorders
Hyponatremia ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Lumbar Spinal Stenosis ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Gastric Cancer ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Uterine Leiomyoma ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Nervous system disorders
Syncope ^{† 1}
# participants affected / at risk	0/129 (0.00%)	2/132 (1.52%)	0/129 (0.00%)
Transient Ischemic Attack ^{† 1}
# participants affected / at risk	0/129 (0.00%)	0/132 (0.00%)	1/129 (0.78%)
Renal and urinary disorders
Urinary Retention ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Renal Failure Acute ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Vascular disorders
Venous Occlusion ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)
Deep Vein Thrombosis ^{† 1}
# participants affected / at risk	0/129 (0.00%)	1/132 (0.76%)	0/129 (0.00%)
Hypertension ^{† 1}
# participants affected / at risk	1/129 (0.78%)	0/132 (0.00%)	0/129 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (12.0)

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided

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

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