Trial | NCT03634475  Report issue

Title

A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis
A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis Having Chronic Inflammation

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    PP-001

  • Study Participants

    18
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 Started
Jan 31
2017
Primary Completion
Nov 30
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Mar 11
2020

Drug PP-001

Drug - no placebo

PP-001 Experimental

Single intravitreal injection of 3 up to 4 doses of PP-001

Criteria 

Inclusion Criteria:

Male or female patients at the age of 18 years or older who have diagnosis of chronic, posterior uveitis, intermediate uveitis or panuveitis

Exclusion Criteria:

Patients receiving specific medication/interventions as specified per protocol
Pregnant or nursing patients
No Results Posted