Primary Open Angle Glaucoma (POAG)Phase 1/2BAHAMANCT07675824
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 1/2 study testing REGN22530 in people with Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Regeneron Pharmaceuticals at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
- What is being tested?
- REGN22530
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2026to 6 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Ocular-specific exclusion criteria apply to the Study Eye only, unless otherwise specified.
- 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
- Note: Other protocol defined Inclusion/ Exclusion criteria apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advanced Research
Deerfield Beach, Florida, 33064
About this study
Official title: A Phase 1/2 Study of REGN22530 in Participants With Primary Open Angle Glaucoma or Ocular Hypertension
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.
Read more
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
- Being tested
- REGN22530
- Keywords
- Intraocular Pressure (IOP), First in Human (FIH), Open Angle Glaucoma (OAG)
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN22530Drug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Part A | Experimental | Not described Receives: Drug: REGN22530 |
| Phase 1 Part B | Experimental | Not described Receives: Drug: REGN22530 |
| Phase 2 Part C | Experimental | Not described Receives: Drug: REGN22530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Part A and B
Measured: Up to week 16
Change from baseline in mean diurnal IOP in the study eye
Part C
Measured: At day 85
Secondary outcomes (4)
Concentrations of REGN22530 in serum
Measured: Up to week 24
Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum
Measured: Up to week 24
Magnitude of ADAs to REGN22530 in serum
Measured: Up to week 24
Occurrence of TEAEs
Part C
Measured: Up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start8 Sep 2026
- Primary completion14 Sep 2029 (estimated)
- Study completion6 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675824
- Sponsor's protocol ID
- R22530-IOP-2558
- Other IDs
- 2026-526004-76-00
- Acronym
- BAHAMA
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of REGN22530 in Participants With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT07675824
- Acronym / sponsor ID
- BAHAMA / R22530-IOP-2558
- Keywords
- Intraocular Pressure (IOP), First in Human (FIH), Open Angle Glaucoma (OAG)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 271 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 14 Sep 2029 (estimated)
- Study completion
- 6 Dec 2029 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Part A | Experimental | Drug: REGN22530 |
| Phase 1 Part B | Experimental | Drug: REGN22530 |
| Phase 2 Part C | Experimental | Drug: REGN22530 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Ocular-specific exclusion criteria apply to the Study Eye only, unless otherwise specified.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN22530Administered per the protocol | Drug | Phase 1 Part A, Phase 1 Part B, Phase 2 Part C |
Primary outcome
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to week 16
Part A and B
Change from baseline in mean diurnal IOP in the study eye
Time frame: At day 85
Part C
4 secondary outcomes
Concentrations of REGN22530 in serum
Time frame: Up to week 24
Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum
Time frame: Up to week 24
Magnitude of ADAs to REGN22530 in serum
Time frame: Up to week 24
Occurrence of TEAEs
Time frame: Up to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REGN22530 in people with Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Regeneron Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.