Testing ONL1204 Opthalmic solution against a placebo for geographic atrophy (GA)

Exclusion

• −Known allergy to fluorescein, povidone iodine, or any ingredients of the study drug or avacincaptad pegol intravitreal solution.
• −Current or planned participation in another investigational clinical study or use of any other investigational drugs or devices at least 6 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → or during the study period without prior written SponsorSponsorThe organisation responsible for the study overall.Read more → approval.
• −Previous ophthalmic disease gene therapy or planned participation in any gene therapy clinical study during the study period.
• −Current or planned use of systemic complement inhibitors during the study period.
• −Any ocular or systemic condition that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study.
• −Treatment with any ocular or systemic medication that is known to be toxic to the lens, retina, or optic nerve (including, but not limited to, aminoglycosides, vancomycin, hydroxychloroquine, interferon, tacrolimus, cisplatin, bis-chloroethyl nitrosourea, carmustine, ethambutol, and tamoxifen) within 90 days prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → or anticipated during the study period.
• −Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary.
• −Study Eye Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −Active ocular or periocular infection in the study eye.
• −Any contraindication to an IVT injection in the study eye.
• −Any media opacity in the study eye that limits visual acuity, clinical visualization of the retina, or retinal imaging as determined by the Investigator.
• −Previous IVT pharmaceutical treatment in the study eye with any agent except Food and Drug Administration (FDA)-approved complement inhibitors and treatment with FDA-approved complement inhibitors within 12 weeks prior to Screening.
• −Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior to Screening.
• −Aphakia with absence of the posterior capsule in the study eye. (Pseudophakia with an open posterior capsule is not exclusionary).
• −Any current evidence or history in the study eye of exudative ("wet") AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator's evaluation and confirmed by the central RC.
• −Any clinically significant retinal disease other than AMD except benign degenerative conditions (eg, Cobblestone degeneration) in the study eye.
• −Fellow Eye Exclusion Criterion:
• −Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than FDA-approved complement inhibitors (pegcetacoplan or avacincaptad pegol IVT solution \[Izervay™\]) during the study period.
• −Either Eye Exclusion Criteria:
• −Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye.
• −GA in either eye due to causes other than AMD.
• −Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period.
• −Any history of incisional retinal surgery in the study eye including but not limited to scleral buckle or vitrectomy. (Retinal laser for a tear or hole 3 months or more prior to Screening is not exclusionary).
• −History of incisional glaucoma surgery including trabeculectomy, tube shunt, or minimally invasive glaucoma surgery in the study eye. (Glaucoma laser procedures performed at least 6 months prior to Screening are not exclusionary).
• −Cataract surgery in the study eye planned or expected during the study period.
• −Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 12 and 13 pertaining to retinal and glaucoma surgery, respectively.
• −Previous therapeutic radiation (including transpupillary thermotherapy, photodynamic therapy, or external-beam) in the region of the study eye.
• −Any ophthalmic condition in either eye that is likely to require surgery during the study period.