REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension

NCT07675824 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: R22530-IOP-25582026-526004-76-00
• Study Type: interventional
• Target: 271
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

Study Arms (3)

Phase 1 Part A

EXPERIMENTAL

Drug: REGN22530

Phase 1 Part B

EXPERIMENTAL

Drug: REGN22530

Phase 2 Part C

EXPERIMENTAL

Drug: REGN22530

Interventions

REGN22530 DRUG

Administered per the protocol

Phase 1 Part A; Phase 1 Part B; Phase 2 Part C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of OHT or POAG of mild to moderate severity as described in the protocol
• 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
• BCVA of ≥55 EDTRS letters (Snellen equivalent of better than or equal to 20/80) in the non-study eye on day 1
• Phakic or pseudophakic with a posterior chamber intraocular lens that has been implanted ≥3 months prior to Screening Visit 1
• Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality posterior segment imaging in the study eye

You may not qualify if:

• OAG or OHT secondary to pigment dispersion, pseudoexfoliation, trauma, uveitis, neovascularization, a vascular disorder, or steroid use
• Congenital or traumatic cataract, or visually significant cataract that is likely to require surgical intervention during the study
• Presence of significant corneal scarring or irregularities that could interfere with reliable IOP measurement
• 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
• History of Selective Laser Trabeculoplasty (SLT) within 6 months prior to day 1
• History of transscleral (including micropulse) or endoscopic cyclophotocoagulation within 1 year prior to day 1

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): July 25, 2029
• Study Completion (Estimated): October 16, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: 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