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Optiquel (B27PD) for Chronic Non-infectious Uveitis
NCT01195948Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2010
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- National Eye Institute
- Modality
- Small Molecules
- Drugs
- B27PD
- Conditions
- noninfectious uveitis (NIU)
01
Overview
Phase 2, randomised, double-blind trial of B27PD in noninfectious uveitis (NIU) (3 arms), sponsored by National Eye Institute. Primary endpoint: Time to Recurrence of Uveitis at 52 weeks. Started Aug 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
B27PD 1 mg
1 mg B27PD 3x/week
B27PD 4 mg
4 mg B27PD 3x/week
Placebo
Placebo 3x/week
03
Who it enrols
Adults with chronic non-infectious uveitis controlled on prednisone (20-40 mg/day), with vision 20/200 or better. Excludes patients with GI diseases affecting absorption, HIV, recent ocular surgery, or use of certain immunosuppressants.
04
Endpoints
Primary
Time to Recurrence of Uveitis
Secondary
Proportion of Participants Determined to be a Treatment Failure
Mean Change in Best-Corrected Visual Acuity
Number of Participants Presenting No Change in Retinal Vessel Leakage
Number of Participants Presenting No Change in Autofluorescence Patterns
Reduction in Exposure to Corticosteroid
Changes in High-speed Indocyanine Green Angiography
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