The purpose of this study is to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma. ONL1204 Ophthalmic Solution is a first-in-class inhibitor of fragment apoptosis stimulator (Fas) receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease. Apoptosis of retinal ganglion cells is associated with progressive glaucoma. Nonclinical data on ONL1204 Ophthalmic Solution suggest that ONL1204 Ophthalmic Solution may inhibit the cell death pathways in these cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
Liquid formulation administered by intravitreal (IVT) injection
Liquid formulation administered by intravitreal (IVT) injection
A sham procedure looks like a real injection into the eye but does not penetrate the eye and it does not have any study drug. The procedure is done by touching the eye surface with a syringe without a needle.
Albury Eye Clinic Wodonga
Albury, New South Wales, Australia
Sydney Eye Surgeons
Hurstville, New South Wales, Australia
PersonalEYES
Parramatta, New South Wales, Australia
Eye Associates
Sydney, New South Wales, Australia
Armadale Eye Clinic
Armadale, Victoria, Australia
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
North West Eye Specialists
Gladstone Park, Victoria, Australia
Centre for Eye Research Australia (CERA)
Melbourne, Victoria, Australia
Waverely Eye Clinic
Waverley, Victoria, Australia
Eye Institute Limited
Remuera, Auckland, New Zealand
...and 1 more locations
Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations
Adverse event reporting, ophthalmic examination to evaluate the anterior and posterior segments of the eye, best-corrected visual acuity, intraocular pressure, electroretinogram, vital signs, clinical laboratory evaluations, and ophthalmic imaging results
Time frame: up to 39 weeks
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