Trial Outcomes & Findings for Efalizumab to Treat Uveitis (NCT NCT00280826)
NCT ID: NCT00280826
Last Updated: 2011-02-02
Results Overview
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.
COMPLETED
PHASE1
6 participants
16 weeks
2011-02-02
Participant Flow
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.
Participant milestones
| Measure |
Efalizumab
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efalizumab to Treat Uveitis
Baseline characteristics by cohort
| Measure |
Efalizumab
n=6 Participants
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
43 years
STANDARD_DEVIATION 23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Analysis was per protocol
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.
Outcome measures
| Measure |
Efalizumab
n=6 Participants
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Number of Participants With Systemic Toxicities, Adverse Events, or Infections
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Analysis was per protocol
Worse eye indicates the eye with the worst visual acuity (VA).
Outcome measures
| Measure |
Efalizumab
n=6 Participants
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT).
|
128 microns
Standard Deviation 105
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Analysis was per protocol
Better eye indicates the eye with better VA.
Outcome measures
| Measure |
Efalizumab
n=6 Participants
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT).
|
57 microns
Standard Deviation 68
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksPopulation: Analysis was per protocol
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.
Outcome measures
| Measure |
Efalizumab
n=6 Participants
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks
|
6.7 ETDRS letters
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline and 16 weeksVisual 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.
Outcome measures
| Measure |
Efalizumab
n=6 Participants
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks
|
1.7 ETDRS letters
Standard Deviation 5.2
|
Adverse Events
Efalizumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Efalizumab
n=6 participants at risk
Treatment of cystoid macular edema due to uveitis
|
|---|---|
|
Eye disorders
Decrease in VA
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Nervous system disorders
Depression
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
General disorders
Dizziness and nausea
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Ear and labyrinth disorders
Headache
|
50.0%
3/6 • Number of events 3 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Reproductive system and breast disorders
Hot flashes
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Lymphocytosis
|
50.0%
3/6 • Number of events 3 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Musculoskeletal and connective tissue disorders
Neck and back pain
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Eye disorders
Ocular discomfort
|
33.3%
2/6 • Number of events 2 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Eye disorders
Pain with eye movements
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Eye disorders
Pterygium
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Ear and labyrinth disorders
Sinusitis
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
33.3%
2/6 • Number of events 2 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
16.7%
1/6 • Number of events 1 • Adverse events were collected between October 2006 and July 2008.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place