Trial Outcomes & Findings for A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis (NCT NCT00333814)

Last Updated: 2011-04-14

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

229 participants

Primary outcome timeframe

Week 8

Results posted on

2011-04-14

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone 350 µg Dexamethasone 350 µg	Dexamethasone 700 µg Dexamethasone 700 µg	Sham Sham
Overall Study STARTED	76	77	76
Overall Study COMPLETED	73	73	71
Overall Study NOT COMPLETED	3	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone 350 µg n=76 Participants Dexamethasone 350 µg	Dexamethasone 700 µg n=77 Participants Dexamethasone 700 µg	Sham n=76 Participants Sham	Total n=229 Participants Total of all reporting groups
Age, Customized <45 years	39 Participants n=5 Participants	43 Participants n=7 Participants	41 Participants n=5 Participants	123 Participants n=4 Participants
Age, Customized Between 45 and 65 years	32 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	87 Participants n=4 Participants
Age, Customized >65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	46 Participants n=7 Participants	51 Participants n=5 Participants	145 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	31 Participants n=7 Participants	25 Participants n=5 Participants	84 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Intent to Treat

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).

Outcome measures

Outcome measures
Measure	Dexamethasone 350 µg n=76 Participants Dexamethasone 350 µg	Dexamethasone 700 µg n=77 Participants Dexamethasone 700 µg	Sham n=76 Participants Sham
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero	35.5 Percentage of Patients	46.8 Percentage of Patients	11.8 Percentage of Patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Population: Intent to Treat

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.

Outcome measures

Outcome measures
Measure	Dexamethasone 350 µg n=76 Participants Dexamethasone 350 µg	Dexamethasone 700 µg n=77 Participants Dexamethasone 700 µg	Sham n=76 Participants Sham
Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)	39.5 Percentage of Patients	42.9 Percentage of Patients	6.6 Percentage of Patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 8

Population: Intent to Treat

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).

Outcome measures

Outcome measures
Measure	Dexamethasone 350 µg n=76 Participants Dexamethasone 350 µg	Dexamethasone 700 µg n=77 Participants Dexamethasone 700 µg	Sham n=76 Participants Sham
Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score	40.8 Percentage of Patients	50.7 Percentage of Patients	15.9 Percentage of Patients

Adverse Events

Dexamethasone 350 µg

Serious events: 6 serious events

Other events: 58 other events

Deaths: 0 deaths

Dexamethasone 700 µg

Serious events: 7 serious events

Other events: 61 other events

Deaths: 0 deaths

Sham

Serious events: 5 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Therapeutic Area Head

Allergan, Inc

Phone: (714) 246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Dexamethasone 350 µg n=74 participants at risk Dexamethasone 350 µg	Dexamethasone 700 µg n=76 participants at risk Dexamethasone 700 µg	Sham n=75 participants at risk Sham
Eye disorders Retinal Detachment	0.00% 0/74 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).	2.6% 2/76 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).	2.7% 2/75 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).
Eye disorders Endophthalmitis	0.00% 0/74 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).	1.3% 1/76 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).	0.00% 0/75 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).
Eye disorders Uveitis	0.00% 0/74 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).	1.3% 1/76 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).	0.00% 0/75 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).
Eye disorders Cataract	1.4% 1/74 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).	0.00% 0/76 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).	1.3% 1/75 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).
Eye disorders Necrotising retinitis	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).
Eye disorders Pupillary disorder	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).
Eye disorders Hypotony of eye	0.00% 0/74 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).	0.00% 0/76 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).	1.3% 1/75 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).
Gastrointestinal disorders Small intestinal obstruction	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).
Infections and infestations Pelvic inflammatory disease	0.00% 0/74 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).	1.3% 1/76 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).	0.00% 0/75 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).
Infections and infestations Pyelonephritis	0.00% 0/74 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).	0.00% 0/76 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).	1.3% 1/75 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).
Investigations HIV test positive	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).
Metabolism and nutrition disorders Ketoacidosis	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/74 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).	0.00% 0/76 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).	1.3% 1/75 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).
Nervous system disorders Cerebellar infarction	0.00% 0/74 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).	1.3% 1/76 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).	0.00% 0/75 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).
Nervous system disorders Cerebrovascular Accident	0.00% 0/74 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).	1.3% 1/76 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).	0.00% 0/75 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).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.4% 1/74 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).	0.00% 0/76 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).	0.00% 0/75 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).