Ocular Hypertension (OHT), Primary Open Angle Glaucoma (POAG)
Conditions
Keywords
Intraocular Pressure (IOP), First in Human (FIH), Open Angle Glaucoma (OAG)
Brief summary
This study will test an experimental drug called REGN22530 ("study drug") to see if it can help treat people with primary open angle glaucoma or ocular hypertension. REGN22530 is an experimental drug that is designed to bind with a protein in the eye that has been shown to cause a buildup of fluid inside the eye and cause increased Intraocular Pressure (IOP). REGN22530 attaches to this protein and stops it from working which may allow more fluid to drain out of the eye and decrease the pressure. The study is looking at: * What side effects REGN22530 might cause * How much REGN22530 is in the blood and eye fluid at different times * If the body has any reactions to REGN22530 (which may cause REGN22530 to not work as well) * How the body and eye pressure respond after having REGN22530, which can help researchers understand why REGN22530 works better in some people than others * How well REGN22530 works
Interventions
DRUGREGN22530
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part A is a non-randomized, open-label, phase 1, FIH Part B is a double-masked, randomized, sham-controlled, phase 1 Part C is a double-masked, randomized, sham-controlled, phase 2
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Diagnosis of OHT or POAG of mild to moderate severity as described in the protocol 2. Best-Corrected Visual Acuity (BCVA) of ≥35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of better than or equal to 20/200) in the study eye on day 1 3. BCVA of ≥55 EDTRS letters (Snellen equivalent of better than or equal to 20/80) in the non-study eye on day 1 4. Phakic or pseudophakic with a posterior chamber intraocular lens that has been implanted ≥3 months prior to Screening Visit 1 5. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality posterior segment imaging in the study eye Key
Exclusion criteria
Ocular-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to week 16 | Part A and B |
| Change from baseline in mean diurnal IOP in the study eye | At day 85 | Part C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of REGN22530 in serum | Up to week 24 | — |
| Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum | Up to week 24 | — |
| Magnitude of ADAs to REGN22530 in serum | Up to week 24 | — |
| Occurrence of TEAEs | Up to week 24 | Part C |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed