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Efalizumab to Treat Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide Arm/Group Description Treatment of cystoid macular edema due to uveitis
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Efalizumab
Hide Arm/Group Description Treatment of cystoid macular edema due to uveitis
Overall Number of Baseline Participants 6
Hide 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
1.Primary Outcome
Title Number of Participants With Systemic Toxicities, Adverse Events, or Infections
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol
Arm/Group Title Efalizumab
Hide 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).
Hide Description Worse eye indicates the eye with the worst visual acuity (VA).
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol
Arm/Group Title Efalizumab
Hide 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).
Hide Description Better eye indicates the eye with better VA.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol
Arm/Group Title Efalizumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol
Arm/Group Title Efalizumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Efalizumab
Hide 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)
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
Hide Arm/Group Description Treatment of cystoid macular edema due to uveitis
All-Cause Mortality
Efalizumab
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Efalizumab
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Nussenblatt, MD, MPH
Organization: National Eye Institute
Phone: 301-496-3123
EMail: drbob@intra.nei.nih.gov
Layout table for additonal information
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