REGN22530 for Primary Open Angle Glaucoma or Ocular Hypertension
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Recruiting
Phase 1Phase 2Interventional Study
Primary Open Angle Glaucoma (POAG)Ocular Hypertension (OHT)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
271 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with primary open angle glaucoma or ocular hypertension. Participants will receive an experimental drug called REGN22530 to see how it affects eye pressure and any side effects it may cause.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with ocular hypertension or primary open angle glaucoma.
I have a best-corrected visual acuity of at least 20/200 in the study eye.
I have a best-corrected visual acuity of at least 20/80 in the non-study eye.
I have had my eye lens implanted for at least 3 months.
I have clear eye media and can undergo imaging.
You may not be able to join if
I have glaucoma or ocular hypertension caused by other medical issues.
I have a cataract that may need surgery during the trial.
I have significant scarring in my cornea affecting eye pressure measurements.
I have had certain glaucoma surgeries in the past.
I have had laser treatment in the past 6 months.
I have had certain types of cyclophotocoagulation in the past year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 an…
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
Trial Locations
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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. …
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
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