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

This study has been completed.

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00486018

First received: June 11, 2007

Last updated: April 25, 2011

Last verified: April 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: Ranibizumab injection 0.3 mg Drug: Ranibizumab injection 0.5 mg Drug: Sham injection

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
No text entered.

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	132	134	131
Received Drug (Safety Population)	131	134	130
COMPLETED	123	128	125
NOT COMPLETED	9	6	6

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]	132	134	131	397
Age [units: years] Mean ± Standard Deviation	65.2 ± 12.7	66.6 ± 11.2	67.5 ± 11.8	66.4 ± 11.9
Age, Customized [units: participants]
< 45 years	8	5	4	17
45 to < 65 years	59	51	51	161
65 to < 85 years	60	74	69	203
≥ 85 years	5	4	7	16
Gender [units: participants]
Female	58	67	60	185
Male	74	67	71	212

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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Measure Type	Secondary
Measure Title	Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
Measure Description	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.
Time Frame	Baseline and 6 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.

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.

Measured Values

	Sham Injection	Ranibizumab Injection 0.3 mg	Ranibizumab Injection 0.5 mg
Number of Participants Analyzed [units: participants]	129	133	130
Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6 [units: Points on the NEI-VFQ-25 subscale] Mean ± Standard Deviation
Baseline	76.4 ± 20.6	76.0 ± 20.5	76.7 ± 18.1
Mean Change from Baseline at Month 6	6.3 ± 15.0	10.3 ± 17.2	11.3 ± 16.6

Statistical Analysis 1 for Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6

Groups ^[1]	Sham Injection vs. Ranibizumab Injection 0.3 mg
Method ^[2]	ANCOVA
P Value ^[3]	0.0248
Difference in Least Squares means ^[4]	3.8
95% Confidence Interval	( 0.5 to 7.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Distance Activities Subscale score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6

Groups ^[1]	Sham Injection vs. Ranibizumab Injection 0.5 mg
Method ^[2]	ANCOVA
P Value ^[3]	0.0014
Difference in Least Squares means ^[4]	5.1
95% Confidence Interval	( 2.0 to 8.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Distance Activities Subscale score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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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
No text entered.

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:	NCT00486018 History of Changes
Other Study ID Numbers:	FVF4165g
Study First Received:	June 11, 2007
Results First Received:	August 16, 2010
Last Updated:	April 25, 2011
Health Authority:	United States: Food and Drug Administration

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