ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration

Prior treatment

• Participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in study eye or systemically for 6 months prior to enrollment, or anticipated participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in study eye or systemically during the study period
• Previous IVT treatment, history of retinal surgery, or other retinal therapeutic procedures in the study eye
• Any ocular or systemic condition that in the opinion of the Investigator makes the subject unsuitable treatment with an investigational agent or that would compromise the safety and efficacy assessments of the trial

Other illness

• Ocular or periocular infection in the study eye

Lab values

• Systemic immunosuppression that may interfere with retinal and cytokine expression including but not limited to glucocorticoids (eg, oral prednisone or dexamethasone); antimetabolites (eg, methotrexate, mycophenolate mofetil, and azathioprine); T-cell inhibitors (eg, cyclosporine, tacrolimus, sirolimus); alkylating agents (eg, cyclophosphamide and chlorambucil); and biologic agents (eg, tumor necrosis factor inhibitors, interferons, lymphocyte inhibitors, and interleukin inhibitors)
• Prior history of systemic use of pentosan polysulfate sodium (trade name Elmiron®)

Age

• An unwillingness to elect to either a) use Age-related Eye Disease Study 2 (AREDS2) formula nutraceutical therapy for the duration of the study or b) choose not to use such therapy for the duration of the study

Other

• GA in either eye due to causes other than AMD
• Intraocular inflammation in the study eye
• Media opacity that would limit baseline visual acuity or clinical visualization of the retina at baseline
• Hyperautofluoresence adjacent to GA lesion in study eye that is focal only

• Males and females, ≥ 55 years old
• Able to give informed consent and attend study visits
• Bilateral GA secondary to AMD without choroidal neovascularization in either eye
• ETDRS BCVA 20/400 (Snellen equivalent) or better in both eyes
• GA ≥1 disc area (DA) (DA, 2.5 mm2)
• If GA in study eye is multifocal, at least one focal lesion must have a DA of ≥ 1.25 mm2
• Entire GA area must be visible within the standard FAF field of view
• Presence of banded or diffuse hyperautofluoresence adjacent to GA lesion in study eye
• Female subjects must be:
• Women of non-childbearing potential, or
• WOCBP with a negative pregnancy test at screening and willing to use permissible methods of contraception for the duration of the study
• Males with female partners of childbearing potential must agree to use permissible methods of contraception and agree to refrain from donating sperm for the duration of the study.