Efalizumab to Treat Uveitis

• ClinicalTrials.gov Identifier: NCT00280826
• Recruitment Status: Completed
• First Posted: January 23, 2006
• Results First Posted: January 27, 2011
• Last Update Posted: February 2, 2011
• Sponsor: National Eye Institute (NEI)
• Information provided by: National Institutes of Health Clinical Center (CC)

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Uveitis; Macular Edema
• Intervention: Drug: Efalizumab
• Enrollment: 6

Participant Flow

Recruitment Details	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

Arm/Group Title	Efalizumab
Arm/Group Description	Treatment of cystoid macular edema due to uveitis
Period Title: Overall Study
Started	6
Completed	6
Not Completed	0

Baseline Characteristics

Arm/Group Title		Efalizumab
Arm/Group Description		Treatment of cystoid macular edema due to uveitis
Overall Number of Baseline Participants		6
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	5 83.3%
	>=65 years	1 16.7%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	6 participants
		43 (23)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	6 participants
	Female	3 50.0%
	Male	3 50.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	6 participants
		6

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Systemic Toxicities, Adverse Events, or Infections
Description	Safety outcomes were recorded by observing and tabulating the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Safety assessments were made by the investigators continuously during the study, with a review of the previous visit interval performed at each scheduled visit. Each participant was also encouraged to report any apparent adverse events between scheduled visits and could return for additional evaluations or treatment between scheduled visits if needed.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Efalizumab
Arm/Group Description:	Treatment of cystoid macular edema due to uveitis
Overall Number of Participants Analyzed	6
Measure Type: Number; Unit of Measure: Participants
	6

2. Secondary Outcome

Title	Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT).
Description	Worse eye indicates the eye with the worst visual acuity (VA).
Time Frame	Baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Efalizumab
Arm/Group Description:	Treatment of cystoid macular edema due to uveitis
Overall Number of Participants Analyzed	6
Mean (Standard Deviation); Unit of Measure: microns
	128 (105)

3. Secondary Outcome

Title	Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT).
Description	Better eye indicates the eye with better VA.
Time Frame	Baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Efalizumab
Arm/Group Description:	Treatment of cystoid macular edema due to uveitis
Overall Number of Participants Analyzed	6
Mean (Standard Deviation); Unit of Measure: microns
	57 (68)

4. Secondary Outcome

Title	Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks
Description	Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.
Time Frame	Baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Efalizumab
Arm/Group Description:	Treatment of cystoid macular edema due to uveitis
Overall Number of Participants Analyzed	6
Mean (Standard Deviation); Unit of Measure: ETDRS letters
	6.7 (6.9)

5. Secondary Outcome

Title	Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks
Description	Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.
Time Frame	Baseline and 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Efalizumab
Arm/Group Description:	Treatment of cystoid macular edema due to uveitis
Overall Number of Participants Analyzed	6
Mean (Standard Deviation); Unit of Measure: ETDRS letters
	1.7 (5.2)

Adverse Events

Time Frame	Adverse events were collected between October 2006 and July 2008.
Adverse Event Reporting Description	Safety outcomes were assessed by observing and tabulating the nature, severity and frequency of systemic toxicities, adverse events and infections throughout the study. Safety assessments were made continuously during the study.
Arm/Group Title	Efalizumab
Arm/Group Description	Treatment of cystoid macular edema due to uveitis
All-Cause Mortality
	Efalizumab
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Efalizumab
	Affected / at Risk (%)	# Events
Total	0/6 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Efalizumab
	Affected / at Risk (%)	# Events
Total	6/6 (100.00%)
Blood and lymphatic system disorders
Neutropenia *	1/6 (16.67%)	1
Ear and labyrinth disorders
Headache *	3/6 (50.00%)	3
Sinusitis *	1/6 (16.67%)	1
Eye disorders
Decrease in VA *	1/6 (16.67%)	1
Dry eye *	1/6 (16.67%)	1
Ocular discomfort *	2/6 (33.33%)	2
Pain with eye movements *	1/6 (16.67%)	1
Pterygium *	1/6 (16.67%)	1
General disorders
Dizziness and nausea *	1/6 (16.67%)	1
Fatigue *	1/6 (16.67%)	1
Musculoskeletal and connective tissue disorders
Neck and back pain *	1/6 (16.67%)	1
Nervous system disorders
Depression *	1/6 (16.67%)	1
Reproductive system and breast disorders
Hot flashes *	1/6 (16.67%)	1
Respiratory, thoracic and mediastinal disorders
Lymphocytosis *	3/6 (50.00%)	3
Sore throat *	1/6 (16.67%)	1
Upper Respiratory Infection *	1/6 (16.67%)	1
Skin and subcutaneous tissue disorders
Skin rash *	2/6 (33.33%)	2
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Robert Nussenblatt, MD, MPH
• Organization: National Eye Institute
• Phone: 301-496-3123
• EMail: 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 by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1167/iovs.10-5896.

• Responsible Party: Robert B. Nussenblatt, M.D./National Eye Institute, National Institutes of Health
• ClinicalTrials.gov Identifier: NCT00280826
• Other Study ID Numbers: 060046; 06-EI-0046 ( Other Identifier: NIH Office of Protocol Services )
• First Submitted: January 21, 2006
• First Posted: January 23, 2006
• Results First Submitted: July 15, 2010
• Results First Posted: January 27, 2011
• Last Update Posted: February 2, 2011