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RecruitingPhase 1 / Phase 2

REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 1/2 Study of REGN22530 in Participants With Primary Open Angle Glaucoma or Ocular Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests REGN22530, an experimental drug, in adults with mild to moderate primary open angle glaucoma or ocular hypertension (high eye pressure). The drug may help fluid drain from the eye and lower eye pressure. Researchers will check how well it works, its side effects, and how the body responds to it.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have mild to moderate primary open angle glaucoma or ocular hypertension, as defined by the study.
  • With glasses or contacts, vision in the study eye must be 20/200 or better on day 1.
  • With glasses or contacts, vision in the other eye must be 20/80 or better on day 1.
  • Have a natural eye lens, or an artificial lens placed behind the iris at least 3 months before the first screening visit.
  • The study eye must be clear enough for pictures of its back. The pupil must open wide enough, and you must be able to hold your gaze steady.

Who can't join

  • These eye-related rules apply only to the study eye.
  • Glaucoma or high eye pressure caused by loose pigment, flaky material in the eye, injury, inflammation, abnormal blood vessels, a blood vessel disorder, or steroid use.
  • A cataract (cloudy eye lens) present from birth or caused by injury, or one that affects vision and will likely need surgery during the study.
  • Scars or an uneven surface on the cornea (the clear front of the eye) that could make eye pressure readings unreliable.
  • Certain past glaucoma procedures, including surgery using cuts or making a drainage pocket, procedures between eye layers, surgery removing drainage tissue, drainage-angle implants other than iStent, or procedures making a hole in the iris. Study rules define which procedures count.
  • Selective laser trabeculoplasty (SLT), a laser treatment to help eye fluid drain, within 6 months before day 1.
  • Cyclophotocoagulation, a laser treatment to reduce eye fluid production, within 1 year before day 1. This includes treatment from outside or inside the eye, including micropulse treatment.
  • Other study rules for who can and cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (1)

FL