- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07675824
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension (BAHAMA)
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.
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
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Key Inclusion Criteria:
- 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:
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Phase 1 Part A
|
Administered per the protocol
|
|
Experimentell: Phase 1 Part B
|
Administered per the protocol
|
|
Experimentell: Phase 2 Part C
|
Administered per the protocol
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsram: Up to week 16
|
Part A and B
|
Up to week 16
|
|
Change from baseline in mean diurnal IOP in the study eye
Tidsram: At day 85
|
Part C
|
At day 85
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concentrations of REGN22530 in serum
Tidsram: Up to week 24
|
Up to week 24
|
|
|
Occurrence of Anti-Drug Antibodies (ADAs) to REGN22530 in serum
Tidsram: Up to week 24
|
Up to week 24
|
|
|
Magnitude of ADAs to REGN22530 in serum
Tidsram: Up to week 24
|
Up to week 24
|
|
|
Occurrence of TEAEs
Tidsram: Up to week 24
|
Part C
|
Up to week 24
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R22530-IOP-2558
- 2026-526004-76-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
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
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .