Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526004-76-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Part A | Experimental |
| |
| Phase 1 Part B | Experimental |
| |
| Phase 2 Part C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN22530 | Drug | Administered per the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Part A and B | Up to week 16 |
| Change from baseline in mean diurnal IOP in the study eye | Part C | At day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Ocular-specific exclusion criteria apply to the Study Eye only, unless otherwise specified.
Note: Other protocol defined Inclusion/ Exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
Not provided
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Not provided
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
Not provided
Not provided
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
Not provided
Not provided
Not provided
| Up to week 24 |
| Occurrence of TEAEs | Part C | Up to week 24 |