A Phase 2/3 interventional study of Dexamethasone and dexamethasone in Intermediate Uveitis and Posterior Uveitis, sponsored by Allergan. Completed at 18 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-14.
Sponsored by Allergan (part of AbbVie) · Phase 2/3, Interventional, and Treatment
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
56 studies on the registry are indexed under Uveitis, Intermediate; 2 are open to participants now.
This study's enrollment of 229 is above the median of 36 across 42 interventional studies indexed under Uveitis, Intermediate.
Browse Uveitis, Intermediate studies →Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted before Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dexamethasone 350 µg
Drug: Dexamethasone
Dexamethasone 700 µg
Drug: dexamethasone
Sham
Drug: Sham injection
Dexamethasone 350 µg; injection drug delivery system at Day 0
Also known as: Posurdex®
Dexamethasone 700 µg injection drug delivery system at Day 0
Also known as: Posurdex®
Sham injection at Day 0
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
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
Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)
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
Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score
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
| Milestone | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham |
|---|---|---|---|
| Started | 76 | 77 | 76 |
| Completed | 73 | 73 | 71 |
| Not completed | 3 | 4 | 5 |
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).
| Percentage of Patients | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham |
|---|---|---|---|
| Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | 35.5 | 46.8 | 11.8 |
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.
| Percentage of Patients | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham |
|---|---|---|---|
| Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | 39.5 | 42.9 | 6.6 |
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).
| Percentage of Patients | Dexamethasone 350 µg | Dexamethasone 700 µg | 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 | 50.7 | 15.9 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone 350 µg | — | 6/74 (8.1%) | 58/74 (78.4%) |
| Dexamethasone 700 µg | — | 7/76 (9.2%) | 61/76 (80.3%) |
| Sham | — | 5/75 (6.7%) | 51/75 (68%) |
| Event | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham |
|---|---|---|---|
| Retinal DetachmentEye disorders | 0/74 | 2/76 | 2/75 |
| CataractEye disorders | 1/74 | 0/76 | 1/75 |
| Necrotising retinitisEye disorders | 1/74 | 0/76 | 0/75 |
| Pupillary disorderEye disorders | 1/74 | 0/76 | 0/75 |
| Small intestinal obstructionGastrointestinal disorders | 1/74 | 0/76 | 0/75 |
| HIV test positiveInvestigations | 1/74 | 0/76 | 0/75 |
| KetoacidosisMetabolism and nutrition disorders | 1/74 | 0/76 | 0/75 |
| Pancreatic CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/74 | 0/76 | 0/75 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/74 | 0/76 | 0/75 |
| Hypotony of eyeEye disorders | 0/74 | 0/76 | 1/75 |
| Event | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham |
|---|---|---|---|
| Conjunctival haemorrhageEye disorders | 13/74 | 23/76 | 16/75 |
| Intraocular pressure increasedInvestigations | 17/74 | 19/76 | 5/75 |
| Eye PainEye disorders | 8/74 | 11/76 | 10/75 |
| IridocyclitisEye disorders | 2/74 | 11/76 | 5/75 |
| UveitisEye disorders | 7/74 | 10/76 | 10/75 |
| Ocular discomfortEye disorders | 3/74 | 10/76 | 6/75 |
| CataractEye disorders | 6/74 | 9/76 | 7/75 |
| Ocular hypertensionEye disorders | 7/74 | 6/76 | 0/75 |
| Conjunctival hyperaemiaEye disorders | 7/74 | 5/76 | 7/75 |
| Visual acuity reducedEye disorders | 7/74 | 3/76 | 6/75 |
| Age, Customized(Participants) | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham | Total |
|---|---|---|---|---|
| <45 years | 39 | 43 | 41 | 123 |
| Between 45 and 65 years | 32 | 28 | 27 | 87 |
| >65 years | 5 | 6 | 8 | 19 |
| Sex: Female, Male(Participants) | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham | Total |
|---|---|---|---|---|
| Female | 48 | 46 | 51 | 145 |
| Male | 28 | 31 | 25 | 84 |
The record gives a start of May 2006, a primary completion of Dec 2008 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2011, 2 years 4 months after primary completion. A results delay was requested in Nov 2009.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone