A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00333814
• Collaborator: (none)
• Enrollment: 229
• Locations: 18
• Arms: 3
• Duration (Months): 35
• Patients Per Site: 12.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

Condition or Disease	Intervention/Treatment	Phase
Intermediate Uveitis; Posterior Uveitis	Drug: Dexamethasone; Drug: dexamethasone; Drug: Sham injection	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 229 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Dexamethasone 350 µg	Drug: Dexamethasone; Dexamethasone 350 µg; injection drug delivery system at Day 0; Other Names: Posurdex®
Active Comparator: 2 Dexamethasone 700 µg	Drug: dexamethasone; Dexamethasone 700 µg injection drug delivery system at Day 0; Other Names: Posurdex®
Sham Comparator: 3 Sham	Drug: Sham injection; Sham injection at Day 0

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero [Week 8]

   Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).

Other Outcome Measures

1. Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) [Week 8]

   Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.

2. Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score [Week 8]

   Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

• Uncontrolled systemic disease

• Any active ocular infections

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Dallas	Texas	United States
2		Sydney		Australia
3		Vienna		Austria
4		São Paulo	São Paulo/SP	Brazil
5		Montreal	Quebec	Canada
6		Prague		Czech Republic
7		Paris		France
8		Heidelberg		Germany
9		Holargos		Greece
10		Hyderabad		India
11		Petah Tikva		Israel
12		Seoul		Korea, Republic of
13		Gdansk		Poland
14		Coimbra		Portugal
15		Johannesburg		South Africa
16		Madrid		Spain
17		Lausanne		Switzerland
18		London		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00333814
• Other Study ID Numbers: 206207-014
• First Posted: Jun 6, 2006
• Last Update Posted: Apr 14, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Uveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

Participant Flow

Arm/Group Title	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Arm/Group Description	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Period Title: Overall Study
STARTED	76	77	76
COMPLETED	73	73	71
NOT COMPLETED	3	4	5

Baseline Characteristics

Arm/Group Title	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham	Total
Arm/Group Description	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham	Total of all reporting groups
Overall Participants	76	77	76	229
Age, Customized (Number) [Number]
<45 years	39 51.3%	43 55.8%	41 53.9%	123 53.7%
Between 45 and 65 years	32 42.1%	28 36.4%	27 35.5%	87 38%
>65 years	5 6.6%	6 7.8%	8 10.5%	19 8.3%
Sex: Female, Male (Count of Participants)
Female	48 63.2%	46 59.7%	51 67.1%	145 63.3%
Male	28 36.8%	31 40.3%	25 32.9%	84 36.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Description	Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Arm/Group Description	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Measure Participants	76	77	76
Number [Percentage of Patients]	35.5	46.8	11.8

2. Other Pre-specified Outcome

Title	Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)
Description	Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Arm/Group Description	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Measure Participants	76	77	76
Number [Percentage of Patients]	39.5	42.9	6.6

3. Other Pre-specified Outcome

Title	Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score
Description	Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Arm/Group Description	Dexamethasone 350 µg	Dexamethasone 700 µg	Sham
Measure Participants	76	77	76
Number [Percentage of Patients]	40.8	50.7	15.9

Adverse Events

Adverse Event Reporting Description	The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated. The Intent-to-Treat population was used for the outcome measure analyses and is calculated as the number of patients that were randomized (or started the study).
Arm/Group Title	Dexamethasone 350 µg		Dexamethasone 700 µg		Sham
Arm/Group Description	Dexamethasone 350 µg		Dexamethasone 700 µg		Sham
All Cause Mortality
	Dexamethasone 350 µg		Dexamethasone 700 µg		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexamethasone 350 µg		Dexamethasone 700 µg		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/74 (8.1%)		7/76 (9.2%)		5/75 (6.7%)
Eye disorders
Retinal Detachment	0/74 (0%)		2/76 (2.6%)		2/75 (2.7%)
Endophthalmitis	0/74 (0%)		1/76 (1.3%)		0/75 (0%)
Uveitis	0/74 (0%)		1/76 (1.3%)		0/75 (0%)
Cataract	1/74 (1.4%)		0/76 (0%)		1/75 (1.3%)
Necrotising retinitis	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Pupillary disorder	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Hypotony of eye	0/74 (0%)		0/76 (0%)		1/75 (1.3%)
Gastrointestinal disorders
Small intestinal obstruction	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Infections and infestations
Pelvic inflammatory disease	0/74 (0%)		1/76 (1.3%)		0/75 (0%)
Pyelonephritis	0/74 (0%)		0/76 (0%)		1/75 (1.3%)
Investigations
HIV test positive	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Metabolism and nutrition disorders
Ketoacidosis	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis	0/74 (0%)		0/76 (0%)		1/75 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Nervous system disorders
Cerebellar infarction	0/74 (0%)		1/76 (1.3%)		0/75 (0%)
Cerebrovascular Accident	0/74 (0%)		1/76 (1.3%)		0/75 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/74 (1.4%)		0/76 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone 350 µg		Dexamethasone 700 µg		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	58/74 (78.4%)		61/76 (80.3%)		51/75 (68%)
Eye disorders
Conjunctival haemorrhage	13/74 (17.6%)		23/76 (30.3%)		16/75 (21.3%)
Eye Pain	8/74 (10.8%)		11/76 (14.5%)		10/75 (13.3%)
Iridocyclitis	2/74 (2.7%)		11/76 (14.5%)		5/75 (6.7%)
Uveitis	7/74 (9.5%)		10/76 (13.2%)		10/75 (13.3%)
Ocular discomfort	3/74 (4.1%)		10/76 (13.2%)		6/75 (8%)
Cataract	6/74 (8.1%)		9/76 (11.8%)		7/75 (9.3%)
Myodesopsia	5/74 (6.8%)		7/76 (9.2%)		5/75 (6.7%)
Ocular hypertension	7/74 (9.5%)		6/76 (7.9%)		0/75 (0%)
Conjunctival hyperaemia	7/74 (9.5%)		5/76 (6.6%)		7/75 (9.3%)
Vision blurred	4/74 (5.4%)		5/76 (6.6%)		3/75 (4%)
Eye irritation	2/74 (2.7%)		4/76 (5.3%)		3/75 (4%)
Intermediate uveitis	0/74 (0%)		4/76 (5.3%)		1/75 (1.3%)
Visual acuity reduced	7/74 (9.5%)		3/76 (3.9%)		6/75 (8%)
Macular oedema	4/74 (5.4%)		3/76 (3.9%)		6/75 (8%)
Eye pruritis	3/74 (4.1%)		3/76 (3.9%)		5/75 (6.7%)
Cataract subcapsular	5/74 (6.8%)		2/76 (2.6%)		4/75 (5.3%)
Conjunctivitis	3/74 (4.1%)		1/76 (1.3%)		4/75 (5.3%)
Eye swelling	1/74 (1.4%)		1/76 (1.3%)		4/75 (5.3%)
Gastrointestinal disorders
Nausea	2/74 (2.7%)		0/76 (0%)		4/75 (5.3%)
Investigations
Intraocular pressure increased	17/74 (23%)		19/76 (25%)		5/75 (6.7%)
Nervous system disorders
Headache	6/74 (8.1%)		5/76 (6.6%)		5/75 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.