In this study, PP-001 is assessed for safety and efficacy in patients diagnosed with non-infectious chronic uveitis. PP-001 is a novel small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. PP-001 will be administered to participants as a single intravitreal injection in ascending doses.
This study assesses safety and efficacy of PP-001 after intravitreal injection in patients diagnosed with non-infectious chronic uveitis. PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. PP-001 is to offer a local treatment alternative to corticosteroids with the objective to reduce or possibly replace steroid intake of non-infectious uveitis patients. In the current study, PP-001 will be injected in ascending doses into the vitreous body of the eye of study participants who suffer from non-infectious uveitis. Participants will be monitored for safety and efficacy evaluation of the study drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Drug - no placebo
University Hospital Vienna
Vienna, Austria
University Hospital Leuven
Leuven, Belgium
Charité Berlin
Berlin, Germany
LMU Munich
Munich, Germany
Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events
To assess safety and tolerability of ascending doses of PP-001 in participants with chronic, non-infectious uveitis when administered as single intravitreal injection
Time frame: 40 days
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University Hospital Muenster
Münster, Germany
University Hospital Tuebingen
Tübingen, Germany
Rotterdam Eye Hospital
Rotterdam, Netherlands
Bristol Eye Hospital
Bristol, United Kingdom
Moorefields Eye Hospital
Moorfields, United Kingdom