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

Launched by ONL THERAPEUTICS · Feb 3, 2021

Keywords

ClinConnect Summary

In this study patients will be enrolled and followed for 24 weeks (natural history phase) at which point they will be randomized to 1 of 2 doses of ONL1204 Ophthalmic Solution or sham. Weeks 24 to 48 make up the Treatment Phase. Patients will be on study for a total of 48 weeks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • GA in either eye due to causes other than AMD
• • 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
• • Intraocular inflammation in the study eye
• • Ocular or periocular infection 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
• • Previous IVT treatment, history of retinal surgery, or other retinal therapeutic procedures in the study eye
• • 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®)
• • 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
• • 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