Study of DE-109 Intravitreal Injections in patients with Uveitis V1
Research type
Research Study
Full title
A Phase III, Multinational, Multicenter, Randomised, Double-Masked, Study Assessing the Safety and Efficacy of Intravitreal Injections of DE-109 (three doses) for the Treatment of active, Non-infectious Uveitis of the Posterior Segment of the eye
IRAS ID
81680
Contact name
Carlos Pavesio
Sponsor organisation
Santen Incorported
Eudract number
2011-001595-19
Clinicaltrials.gov Identifier
Research summary
Uveitis is an intraocular inflammation disorder classified by the location in the uvea. Posterior uveitis can involve vitreous, choroid, retina, and/or optic nerve. In western countries 10% of the visual handicap is due to uveitis. There can be cumulative structural damage and loss of vision due to the recurrent inflammation episodes. Standard treatments include corticosteroids, periocular injection and Intravitreal implants. Long-term data has shown patients who have had implants sometimes require cataract extraction and treatment to reduce intraocular pressure. Systemic corticosteroids are used due to recurring inflammation. This can lead to Cushingoid syndrome, diabetes, osteoporotic bones and metabolic disturbances. Systemic immunosuppressive agents and biologic agents have been used. There are a variety of treatment options, however the side effects associated with the use of corticosteroids and the inconvenience of close monitoring required with systemic immunosuppressive and biologic agents, means that there is an unmet need for more treatments. The study drug Sirolimus is being tested in a formulation called DE-109. DE-109 is given by intravitreal injection and is thought to inhibit inflammation. DE-109 has been administered to patients with non-infectious uveitis in a Phase I/II study that is currently being conducted in the US The interim results indicate the study drug is generally safe and well tolerated. The purpose of this study is to investigate how well three different strengths of DE-109 work to treat uveitis and how well they are tolerated. About 500 participants will take part with about 30 being in the UK. Patients will take part for 13 months and will make 12 visits to the hospital. Study assessments include physical examinations, vital signs, questionnaires, pregnancy testing, blood and urine tests, slit lamp biomicroscopy, endothelial cell count, intraocular pressure, indirect opthalmoscopy, fundus photographyflurescein angiography and optical coherence tomography. The study is sponsored by Santen Incorporated.
REC name
London - City & East Research Ethics Committee
REC reference
11/LO/1226
Date of REC Opinion
18 Nov 2011
REC opinion
Further Information Favourable Opinion