Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    "Choroiditis" | "BB 1101"

A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior 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: NCT00333814
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : April 14, 2011
Last Update Posted : April 14, 2011
Sponsor:
Information provided by:
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Intermediate Uveitis
Posterior Uveitis
Interventions Drug: Dexamethasone
Drug: dexamethasone
Drug: Sham injection
Enrollment 229
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone 350 µg Dexamethasone 700 µg Sham
Hide 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
Arm/Group Title Dexamethasone 350 µg Dexamethasone 700 µg Sham Total
Hide Arm/Group Description Dexamethasone 350 µg Dexamethasone 700 µg Sham Total of all reporting groups
Overall Number of Baseline Participants 76 77 76 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 76 participants 229 participants
<45 years 39 43 41 123
Between 45 and 65 years 32 28 27 87
>65 years 5 6 8 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 76 participants 229 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%
1.Primary Outcome
Title Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Dexamethasone 350 µg Dexamethasone 700 µg Sham
Hide Arm/Group Description:
Dexamethasone 350 µg
Dexamethasone 700 µg
Sham
Overall Number of Participants Analyzed 76 77 76
Measure Type: Number
Unit of Measure: 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Dexamethasone 350 µg Dexamethasone 700 µg Sham
Hide Arm/Group Description:
Dexamethasone 350 µg
Dexamethasone 700 µg
Sham
Overall Number of Participants Analyzed 76 77 76
Measure Type: Number
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Dexamethasone 350 µg Dexamethasone 700 µg Sham
Hide Arm/Group Description:
Dexamethasone 350 µg
Dexamethasone 700 µg
Sham
Overall Number of Participants Analyzed 76 77 76
Measure Type: Number
Unit of Measure: Percentage of Patients
40.8 50.7 15.9
Time Frame [Not Specified]
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
Hide Arm/Group Description Dexamethasone 350 µg Dexamethasone 700 µg Sham
All-Cause Mortality
Dexamethasone 350 µg Dexamethasone 700 µg Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone 350 µg Dexamethasone 700 µg Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/74 (8.11%)   7/76 (9.21%)   5/75 (6.67%) 
Eye disorders       
Retinal Detachment  1  0/74 (0.00%)  2/76 (2.63%)  2/75 (2.67%) 
Endophthalmitis  1  0/74 (0.00%)  1/76 (1.32%)  0/75 (0.00%) 
Uveitis  1  0/74 (0.00%)  1/76 (1.32%)  0/75 (0.00%) 
Cataract  1  1/74 (1.35%)  0/76 (0.00%)  1/75 (1.33%) 
Necrotising retinitis  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Pupillary disorder  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Hypotony of eye  1  0/74 (0.00%)  0/76 (0.00%)  1/75 (1.33%) 
Gastrointestinal disorders       
Small intestinal obstruction  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Infections and infestations       
Pelvic inflammatory disease  1  0/74 (0.00%)  1/76 (1.32%)  0/75 (0.00%) 
Pyelonephritis  1  0/74 (0.00%)  0/76 (0.00%)  1/75 (1.33%) 
Investigations       
HIV test positive  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Metabolism and nutrition disorders       
Ketoacidosis  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders       
Ankylosing spondylitis  1  0/74 (0.00%)  0/76 (0.00%)  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic Carcinoma  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Nervous system disorders       
Cerebellar infarction  1  0/74 (0.00%)  1/76 (1.32%)  0/75 (0.00%) 
Cerebrovascular Accident  1  0/74 (0.00%)  1/76 (1.32%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/74 (1.35%)  0/76 (0.00%)  0/75 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexamethasone 350 µg Dexamethasone 700 µg Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   58/74 (78.38%)   61/76 (80.26%)   51/75 (68.00%) 
Eye disorders       
Conjunctival haemorrhage  1  13/74 (17.57%)  23/76 (30.26%)  16/75 (21.33%) 
Eye Pain * 1  8/74 (10.81%)  11/76 (14.47%)  10/75 (13.33%) 
Iridocyclitis  1  2/74 (2.70%)  11/76 (14.47%)  5/75 (6.67%) 
Uveitis  1  7/74 (9.46%)  10/76 (13.16%)  10/75 (13.33%) 
Ocular discomfort * 1  3/74 (4.05%)  10/76 (13.16%)  6/75 (8.00%) 
Cataract  1  6/74 (8.11%)  9/76 (11.84%)  7/75 (9.33%) 
Myodesopsia  1  5/74 (6.76%)  7/76 (9.21%)  5/75 (6.67%) 
Ocular hypertension  1  7/74 (9.46%)  6/76 (7.89%)  0/75 (0.00%) 
Conjunctival hyperaemia  1  7/74 (9.46%)  5/76 (6.58%)  7/75 (9.33%) 
Vision blurred * 1  4/74 (5.41%)  5/76 (6.58%)  3/75 (4.00%) 
Eye irritation * 1  2/74 (2.70%)  4/76 (5.26%)  3/75 (4.00%) 
Intermediate uveitis  1  0/74 (0.00%)  4/76 (5.26%)  1/75 (1.33%) 
Visual acuity reduced  1  7/74 (9.46%)  3/76 (3.95%)  6/75 (8.00%) 
Macular oedema  1  4/74 (5.41%)  3/76 (3.95%)  6/75 (8.00%) 
Eye pruritis * 1  3/74 (4.05%)  3/76 (3.95%)  5/75 (6.67%) 
Cataract subcapsular  1  5/74 (6.76%)  2/76 (2.63%)  4/75 (5.33%) 
Conjunctivitis  1  3/74 (4.05%)  1/76 (1.32%)  4/75 (5.33%) 
Eye swelling * 1  1/74 (1.35%)  1/76 (1.32%)  4/75 (5.33%) 
Gastrointestinal disorders       
Nausea * 1  2/74 (2.70%)  0/76 (0.00%)  4/75 (5.33%) 
Investigations       
Intraocular pressure increased  1  17/74 (22.97%)  19/76 (25.00%)  5/75 (6.67%) 
Nervous system disorders       
Headache * 1  6/74 (8.11%)  5/76 (6.58%)  5/75 (6.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc
Phone: (714) 246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00333814     History of Changes
Other Study ID Numbers: 206207-014
First Submitted: June 2, 2006
First Posted: June 6, 2006
Results First Submitted: October 12, 2010
Results First Posted: April 14, 2011
Last Update Posted: April 14, 2011