Active Noninfectious Uveitis Affecting the Posterior Segment
Conditions
Keywords
NIU-PS, Intermediate, Posterior, Panuveitis, Anterior, Uveitis, Angiographic Cystoid Macular Edema (CME), Retinal vascular leakage
Brief summary
This study is researching an experimental drug called REGN7041 (also referred to as "study drug"). The study is focused on patients who have active inflammation inside of the eye without any signs of infection. The aim of the study is to see how safe and tolerable the study drug is. This is the first time the study drug is being tested in humans. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood and the fluid in the eye at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Interventions
DRUGREGN7041
Administered as per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Diagnosis of non-infectious anterior, intermediate, posterior or panuveitis (For anterior uveitis, there must be evidence of inflammation affecting the posterior segment), as defined in the protocol 2. Active disease at baseline, as defined in the protocol 3. Part A only: Best Corrected Visual Acuity (BCVA) of ≤65 and \>10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of worse than or equal to 20/50 and better than 20/630) at the screening visit and on day 1 4. Part B only: BCVA of \<75 and \>10 ETDRS letters (Snellen equivalent of worse than 20/32 and better than 20/630) at the screening visit and on day 1 Key
Exclusion criteria
1. BCVA of ≤30 ETDRS letters (Snellen equivalent of 20/250 or worse) at the screening visit and/or on day 1 2. Intraocular Pressure (IOP) \<5 mm Hg at the screening visit and/or on day 1 3. IOP \>25 mm Hg on day 1. Participants are permitted to take IOP-lowering eye drops 4. Confirmed or suspected infectious uveitis, as defined in the protocol NOTE: Other Protocol-Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Through Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Concentrations of REGN7041 in serum | Through Week 24 |
| Incidence of Anti-Drug Antibodies (ADAs) to REGN7041 in serum | Through Week 24 |
| Magnitude of ADAs to REGN7041 in serum | Through Week 24 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed