Recruiting
Phase 1
Phase 2

REGN22530

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07675824

Conditions

Primary Open Angle Glaucoma (POAG)

Ocular Hypertension (OHT)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN22530

Study Details

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

Conditions

Primary Open Angle Glaucoma (POAG)

Ocular Hypertension (OHT)

Study ID

NCT07675824

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Dec 6, 2029

Anticipated

Primary completion date

Sep 14, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 exclusion criteria apply to the Study Eye only, unless otherwise specified.

1. OAG or OHT secondary to pigment dispersion, pseudoexfoliation, trauma, uveitis, neovascularization, a vascular disorder, or steroid use
2. Congenital or traumatic cataract, or visually significant cataract that is likely to require surgical intervention during the study
3. Presence of significant corneal scarring or irregularities that could interfere with reliable IOP measurement
4. Prior incisional or bleb-forming glaucoma surgery, suprachoroidal procedures, Trabecular Meshwork (TM)-stripping Microinvasive Glaucoma Surgery (MIGS), angle-based implants other than iStent or iridectomy/iridotomy as described in the protocol
5. History of Selective Laser Trabeculoplasty (SLT) within 6 months prior to day 1
6. History of transscleral (including micropulse) or endoscopic cyclophotocoagulation within 1 year prior to day 1

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Study Design

Enrollment

271 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1 Part A

experimental: Phase 1 Part B

experimental: Phase 2 Part C

Interventions

REGN22530

Administered per the protocol

Primary outcome measure

  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to week 16 ]
  • Change from baseline in mean diurnal IOP in the study eye [ Time Frame: At day 85 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Advanced Research

Recruiting

Deerfield Beach, Florida, United States, 33064

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • Intraocular Pressure (IOP)
  • First in Human (FIH)
  • Open Angle Glaucoma (OAG)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.