REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- REGN22530
Treatment groups
271 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov