Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorONL Therapeutics
About this trial
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. Associated with aging, cigarette smoking, obesity, diets low in certain nutrients, a lifestyle related to cardiac risk, and a growing list of genetic factors, AMD is becoming an increasingly prevalent public health concern, especially as the global population ages. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease, including models of dry AMD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 study entry, or surgically sterile. If of childbearing potential, a negative urine pregnancy test is required at Screening and prior to the administration of study drug at each visit.
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 last dose of study drug.
Disqualifiers
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 Sponsor 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 Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study.
Trial design
Design model
Parallel
Treatments tested in this trial
ONL1204 Opthalmic solution
DrugLiquid formulation ONL1204 Ophthalmic Solution administered by intravitreal (IVT) injection
Avacincaptad Pegol intravitreal solution
DrugLiquid formulation Avacincaptad Pegol administered by intravitreal (IVT) injection
Sham
Other interventionSham injection
Treatment groups
324 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: ONL1204 Opthalmic solution (1 of 6 Treatment Groups) administered by intravitreal injectionActive comparator 1 intervention
Group B: ONL1204 Opthalmic solution (2 of 6 Treatment Groups) administered by intravitreal injectionActive comparator 1 intervention
Group C: ONL1204 Opthalmic solution (3 of 6 Treatment Groups) administered by intravitreal injectionExperimental treatment 1 intervention
Group D: Sham Comparator (4 of 6 Treatment Groups)Sham comparator 1 intervention
Group E: Sham Comparator (5 of 6 Treatment Groups)Sham comparator 1 intervention
Group F: Avacincaptad pegol intravitreal solution (6 of 6 Treatment Groups - US ONLY)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint
GA lesion area
Time frame
From enrollment to the end of treatment at 48 weeks.Secondary outcomes
1
Secondary Endpoints (Safety)
Incidence of new active exudative macular neovascularization (eMNV) in the study eye
Time frame
From enrollment to the end of treatment at 48 weeks.2
Secondary Endpoints (Safety)
Incidence of Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) loss
Time frame
From enrollment to the end of treatment at 48 weeks.Sponsors and contacts
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Source ClinicalTrials.gov