Efalizumab to Treat Uveitis

This study has been completed.

Study NCT00280826 Information provided by National Institutes of Health Clinical Center (CC)

First Received on January 21, 2006. Last Updated on January 28, 2011 History of Changes

Results First Received: July 15, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Uveitis Macular Edema
Intervention:	Drug: Efalizumab

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
Six participants were enrolled from October 2006 through December 2007. Participants were recruited from the National Eye Institute's (NEI) uveitis clinic. In addition, the study was posted on Clinical Trials.gov, the NEI and the Clinical Center's (CC) websites. Self referral and referral from outside physicians was also permitted.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Six participants were enrolled from October 2006 through December 2007.

Participants were recruited from the National Eye Institute's (NEI) uveitis clinic. In addition, the study was posted on Clinical Trials.gov, the NEI and the Clinical Center's (CC) websites. Self referral and referral from outside physicians was also permitted.

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
Efalizumab	Treatment of cystoid macular edema due to uveitis

Participant Flow: Overall Study

	Efalizumab
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Efalizumab	Treatment of cystoid macular edema due to uveitis

Baseline Measures

	Efalizumab
Number of Participants [units: participants]	6
Age [units: participants]
<=18 years	0
Between 18 and 65 years	5
>=65 years	1
Age [units: years] Mean ± Standard Deviation	43 ± 23
Gender [units: participants]
Female	3
Male	3
Region of Enrollment [units: participants]
United States	6

Outcome Measures

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1. Primary:

Number of Participants With Systemic Toxicities, Adverse Events, or Infections [ Time Frame: 16 weeks ]

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2. Secondary:

Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT). [ Time Frame: Baseline and 16 weeks ]

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3. Secondary:

Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT). [ Time Frame: Baseline and 16 weeks ]

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4. Secondary:

Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks [ Time Frame: Baseline and 16 weeks ]

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5. Secondary:

Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks [ Time Frame: Baseline and 16 weeks ]

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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:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: Robert Nussenblatt, MD, MPH
Organization: National Eye Institute
phone: 301-496-3123
e-mail: drbob@intra.nei.nih.gov

Publications:

Djalilian AR, Nussenblatt RB. Immunosuppression in uveitis. Ophthalmol Clin North Am. 2002 Sep;15(3):395-404, viii. Review.

Leonardi CL. Efalizumab: an overview. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S98-104. Review.

Whitcup SM, Hikita N, Shirao M, Miyasaka M, Tamatani T, Mochizuki M, Nussenblatt RB, Chan CC. Monoclonal antibodies against CD54 (ICAM-1) and CD11a (LFA-1) prevent and inhibit endotoxin-induced uveitis. Exp Eye Res. 1995 Jun;60(6):597-601.

Publications automatically indexed to this study:

Faia LJ, Sen HN, Li Z, Yeh S, Wroblewski KJ, Nussenblatt RB. Treatment of inflammatory macular edema with humanized anti-CD11a antibody therapy. Invest Ophthalmol Vis Sci. 2011 Sep 1;52(9):6919-24. Print 2011 Aug.

Responsible Party:	Robert B. Nussenblatt, M.D./National Eye Institute, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00280826 History of Changes
Other Study ID Numbers:	060046, 06-EI-0046
Study First Received:	January 21, 2006
Results First Received:	July 15, 2010
Last Updated:	January 28, 2011
Health Authority:	United States: Food and Drug Administration