A Study of PER-001 in Participants With Open-Angle Glaucoma

Korábbi kezelés

• Retinal laser within 3 months prior to Day 1
• Intraocular surgery, including cataract surgery and Minimally Invasive Glaucoma
• Surgery (MIGS), within 3 months prior to Day 1
• Change in IOP lowering therapy within 6 weeks prior to Screening and/or anticipated change in IOP lowering therapy or treatment during the study Worse than mild non-proliferative diabetic retinopathy (Note: stable mild background diabetic retinopathy is permitted)

Más betegség

• Any condition which, in the opinion of the investigator, would preclude the participant's ability to comply with study requirements including completion of the study (including but not limited to diagnosis of dementia, Alzheimer's, and/or other neurological disease or physical incapacity)
• History of vitrectomy surgery or retinal detachment or macular hole (Stage 3 or 4)
• Any active uveitis and/or vitritis or history of idiopathic or autoimmune-associated uveitis
• History of recurrent infectious or inflammatory ocular disease

Egyéb

• Blood pressure >140/90 mmHg or <90/60 mmHg at Screening
• Females who are pregnant, nursing, or planning a pregnancy during the study
• Any significant media opacity which precludes clinical evaluation and imaging of the retina
• Aphakia or absence of posterior capsule
• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis (Note: mild blepharitis is permitted if stable)
• Central serous retinopathy
• Non-glaucomatous optic neuropathy

• For Phase 1 and Phase 2a:
• Must be ≥ 18 years of age at the time of signing the informed consent
• A negative pregnancy test for females of childbearing potential at Screening (serum) and Day 1 (urine).
• IOP 6 to 25 mmHg (inclusive) at Screening in potentially eligible eye(s)
  • Phase 1:
• Best corrected visual acuity (BCVA) LogMAR score 1.0 or better at Screening in at least one eye and prior to randomization at Day 1 in the study eye
• Diagnosis of advanced or severe primary OAG including normal tension, pseudoexfoliation and pigment dispersion
  • Phase 2:
• BCVA LogMAR score 0.5 or better at Screening in at least one eye and prior to randomization at Day 1 in the study eye
• Primary OAG that is progressing in the study eye