Phase 2
Completed N=12
A Safety Study of Intravitreal PP-001 in Patients With Chronic, Non-Infectious Uveitis
Source: ClinicalTrials.gov NCT03634475 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events — 12 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Safety and Tolerability by Determining Treatment Emergent Adverse Events |
12 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03634475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.