Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (EXCITE)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00275821

First received: January 11, 2006

Last updated: February 22, 2011

Last verified: February 2011

History of Changes

Results First Received: December 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Age Related Macular Degeneration
Interventions:	Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly Drug: Ranibizumab 0.3 mg monthly

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
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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
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly	Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly	Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.3 mg Monthly	Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Participant Flow: Overall Study

	Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly	Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly	Ranibizumab 0.3 mg Monthly
STARTED	120	118	115
COMPLETED	106	95	103
NOT COMPLETED	14	23	12
Adverse Event	4	12	5
Administrative problems	3	4	4
Withdrawal by Subject	0	2	1
Lost to Follow-up	0	1	1
Death	0	2	1
Lack of Efficacy	2	1	0
Protocol Violation	5	1	0

Baseline Characteristics

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Reporting Groups

	Description
Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly	Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly	Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.3 mg Monthly	Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Total	Total of all reporting groups

Baseline Measures

	Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly	Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly	Ranibizumab 0.3 mg Monthly	Total
Number of Participants [units: participants]	120	118	115	353
Age, Customized [units: Participants]
50 - < 65	13	12	10	35
65 - < 75	37	28	45	110
75 - < 85	61	72	46	179
≥ 85	9	6	14	29
Gender [units: participants]
Female	70	73	66	209
Male	50	45	49	144

Outcome Measures

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1. Primary:

Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ]

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2. Secondary:

Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ]

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3. Secondary:

Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ]

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4. Secondary:

Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ]

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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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00275821 History of Changes
Other Study ID Numbers:	CRFB002A2302
Study First Received:	January 11, 2006
Results First Received:	December 20, 2010
Last Updated:	February 22, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

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