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Tests treatment safety and results for Geographic Atrophy (GA)
Official title Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
ClinicalTrials.gov ID: NCT06659445
What this study is testing
What is ONL1204 Opthalmic solution?
ONL1204 Opthalmic solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for geographic atrophy (ga).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to collect efficacy and safety information of intravitreal injection for 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies in patients with GA associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability and legal blindness globally.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 55 years of age or older at Screening.
- Able and willing to give informed consent and attend study visits.
- Women or intersex individuals must be willing to use 2 forms of effective contraception during the study and for at least 90 days following the last...
- Men or intersex individuals with partners of childbearing potential must be willing to use permissible methods of contraception and refrain from...
- If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar nutraceutical therapy at Screening, patient must be willing to continue...
You likely can't join if
- Current or planned participation in another investigational clinical study or use of any other investigational drugs or devices at least 6 months...
- 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 Investigator, makes the patient unsuitable for treatment with an investigational drug or...
- 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...
- Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary.
See the full eligibility criteria
Who can join
- 55 years of age or older at Screening.
- Able and willing to give informed consent and attend study visits.
- Women or intersex individuals must be willing to use 2 forms of effective contraception during the study and for at least 90 days following the last dose of study drug, be postmenopausal for at least 12 months prior to...
- Men or intersex individuals with partners of childbearing potential must be willing to use permissible methods of contraception and refrain from sperm donation during the study and for at least 90 days following the...
- If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or...
- BCVA of 24 letters or more using ETDRS charts in the study eye at Screening.
- Intraocular pressure (IOP) of 22 mmHg or lower in the study eye at Screening. The GA lesion must meet all the following criteria:
- Non-foveal GA associated with AMD without eMNV in the study eye per Investigator's evaluation and as confirmed by the central RC.
- GA ≥0.85 disc area (DA) (2.125 mm2) and ≤8.05 DA (20.125 mm2) in the study eye as confirmed by the central RC.
- If GA in the study eye is multifocal, at least 1 focal lesion must be ≥0.425 DA (1.063 mm2) as confirmed by the central RC.
- Non-foveal GA (GA lesion up to the fovea, but not subfoveal) with the lesion's closest border 1725 microns or less from the foveal center in the study eye, as confirmed by the central RC.
- The entire GA lesion in the study eye must be completely visualized on the macula-centered FAF image, must be able to be imaged in its entirety, and must not be contiguous with any areas of peripapillary atrophy per the...
- A pattern of hyper-autofluorescence in the junctional zone of GA in the study eye must be present as confirmed by the central RC. Fellow Eye Inclusion Criterion:
- BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening.
What rules you out
- Current or planned participation in another investigational clinical study or use of any other investigational drugs or devices at least 6 months prior to enrollment or during the study period without prior written...
- 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 Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or how well it works assessments of...
- 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...
- Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary.
- Known allergy to fluorescein, povidone iodine, or any ingredients of the study drug or avacincaptad pegol intravitreal solution.
- Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period. Study Eye Exclusion Criteria:
- 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...
- 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...
- Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior to Screening.
- Cataract surgery in the study eye planned or expected during the study period.
- 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...
- Any clinically significant retinal disease other than AMD except benign degenerative conditions (eg, Cobblestone degeneration) in the study eye.
- 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. 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...
- 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.
- Any ophthalmic condition in either eye that is likely to require surgery during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Glendale, California, United States
- Huntington Beach, California, United States
- Palm Desert, California, United States
- Sacramento, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- Waterford, Connecticut, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Elmhurst, Illinois, United States
- Oak Park, Illinois, United States
- Carmel, Indiana, United States
- Towson, Maryland, United States
+ 34 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Phoenix, Arizona, United States; Bakersfield, California, United States; Beverly Hills, California, United States; Glendale, California, United States; Huntington Beach, California, United States and 48 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.