ClinicalTrials.gg
RecruitingNCT07675824BAHAMAUpdated Sep 28, 2026

REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 1/2 interventional study of REGN22530 in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT), sponsored by Regeneron Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Regeneron Pharmaceuticals · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Sep 28, 2026Now RecruitingFirst site in United States+4 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
271
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Primary Open Angle Glaucoma (POAG)
  • Ocular Hypertension (OHT)

Keywords

  • Intraocular Pressure (IOP)
  • First in Human (FIH)
  • Open Angle Glaucoma (OAG)
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 271 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
271 participants (estimated)

Study arms

  • Experimental
    Phase 1 Part A

    Drug: REGN22530

  • Experimental
    Phase 1 Part B

    Drug: REGN22530

  • Experimental
    Phase 2 Part C

    Drug: REGN22530

Interventions

  • DrugREGN22530

    Administered per the protocol

06

What researchers measure

Primary outcomes

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Part A and B

    Time frame: Up to week 16

  2. Change from baseline in mean diurnal IOP in the study eye

    Part C

    Time frame: At day 85

Secondary outcomes

  1. Concentrations of REGN22530 in serum

    Time frame: Up to week 24

  2. Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum

    Time frame: Up to week 24

  3. Magnitude of ADAs to REGN22530 in serum

    Time frame: Up to week 24

  4. Occurrence of TEAEs

    Part C

    Time frame: Up to week 24

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
1 site added — first site in United States
Show site
  • Advanced Research · Deerfield Beach, United States
Sep 28, 2026
Start date
Jul 23, 2026→Sep 8, 2026 (actual)
Sep 28, 2026
Primary completion
Jul 25, 2029→Sep 14, 2029
Sep 28, 2026
Study completion
Oct 16, 2029→Dec 6, 2029
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • Advanced Research · Deerfield Beach, United States
    Start date Jul 23, 2026→Sep 8, 2026 (now actual)
    Primary completion Jul 25, 2029→Sep 14, 2029
    Study completion Oct 16, 2029→Dec 6, 2029
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07675824
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Sep 8, 2026
Primary completion
Sep 14, 2029 (estimated)
Completion
Dec 6, 2029 (estimated)
Last update
Sep 28, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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