Neovascular age-related macular degeneration (wet AMD) MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: OPT-302
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a hum
Sponsors
Opthea Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: STUDY EYE 1. Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal CNV lesion (1-199 µm from the fovea) with subfoveal involvement (demonstrated by leakage on fluorescein angiography (FA) and/or intra-retinal or sub-retinal fluid on spectral-domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD). Active CNV as measured on FA must constitute at least 50% of the lesion area, with a total lesion size of = 30.5 mm2. The lesion may contain classic and/or occult CNV, but any occult CNV present must measure =65 years) yes F.1.3.1 Number of subjects for this age range 326
Exclusion criteria
Exclusion criteria: STUDY EYE 1. Any previous treatment for wet AMD, including anti-VEGF-A therapy, photodynamic therapy, thermal laser, external beam radiation, steroids or other AMD therapy in the Study Eye. Oral supplements of vitamins and minerals are permitted. 2. Clinically significant ocular disorders (other than wet AMD), which may, in the Investigator’s opinion, interfere with assessment of visual acuity, assessment of safety, OCT, fluorescein angiography or fundus photography; 3. Haemorrhage measuring more than 50% of total lesion area; 4. Fibrosis involving either the fovea centre or measuring more than 25% of the total lesion area and/or juxtafoveal or sub-foveal geographic atrophy. 5. Choroidal neovascularisation due to causes other than AMD, including presumed ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, and pathological myopia. Participants with retinal angiomatous proliferation (RAP) or idiopathic polypoidal choroidal vasculopathy (IPCV) are not excluded. 6. Cloudy ocular media, or inadequate pupillary dilatation, so as to prevent collection of fundus photographs and/or fluorescein angiograms of sufficient quality to be analysed by the Independent Reading Centre. 7. Presence of intraocular inflammation (= trace cell or flare), significant epiretinal membrane or vitreomacular traction, macular hole or vitreous haemorrhage. 8. Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is permitted if it occurred as a result of a YAG laser posterior capsulotomy in association with prior posterior chamber intraocular lens implant. 9. History of idiopathic or autoimmune-associated uveitis. 10. Any current ocular or periocular infection (participants may be re-screened once the infection has resolved or responded fully to treatment). 11. Intraocular pressure of greater than 25 mmHg (including participants with glaucoma or ocular hypertension who are stabilised on therapy). 12. Myopia, or known former myopia, with a spherical equivalent of greater than 8 dioptres. 13. Intraocular surgery within 6 months prior to screening, except for cataract surgery that is excluded within 3 months of Screening. 14. History of any of the following conditions or procedures: Rhegmatogenous retinal detachment, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, or corneal transplant. 15. Prior pars plana vitrectomy. 16. Presence of an intravitreal device. 17. Retinopathy from diabetes, sickle cell disease or other cause. NON-STUDY EYE 1. History of idiopathic, autoimmune-associated, or infectious uveitis. GENERAL 1. Poorly controlled diabetes mellitus (defined as HbA1c > 7.0%). 2. Administration of systemic steroids within 3 months of screening. 3. Symptoms of heart failure leading to marked limitation on physical activity, or inability to perform any physical activity without discomfort. 4. Unstable angina, myocardial infarction or coronary artery revascularisation within 6 months of screening. 5. Ventricular t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Mean change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) letters to Week 24 (Visit 8);Timepoint(s) of evaluation of this end point: Week 24 (Visit 8);Main Objective: Determine the efficacy of two different doses of intravitreal OPT-302 when administered in combination with ranibizumab in participants with wet AMD; Secondary Objective: * Determine the proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 24; * Determine the area under the ETDRS BCVA over time curve; * Determine the change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) from Baseline to Week 24; * Determine the change in sub-retinal fluid on SD-OCT from Baseline to Week 24; * Determine the presence or absence of intra-retinal fluid on SD-OCT from Baseline to Week 24; * Determine the proportion of participants losing 15 or more letters (on ETDRS BCVA chart) from Baseline to the Week 24 Visit; * Determine the safety of OPT-302 in combination with ranibizumab; * Determine the pharmacokinetic parameters of OPT-302; * Determine the incidence of anti-OPT-302 antibody (ADA) formation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 24 (Visit 8); Secondary end point(s): * The proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to the Week 24 Visit; * Area under the ETDRS BCVA-over-time curve; * Change in CST on SD-OCT from Baseline to Week 24; * Change in sub-retinal fluid on SD-OCT from Baseline to Week 24; * Presence or absence of intra-retinal fluid determined by the presence or absence of intra-retinal cysts on SD-OCT from Baseline to Week 24; * Proportion of participants losing 15 or more letters (on ETDRS BCVA chart) from Baseline to the Week 24 Visit; * Incidence of ocular and non-ocular adverse events (AEs); * OPT-302 pharmacokinetic parameters; * Participant incidence of ADA formation. | — |
Countries
Czech Republic, France, Hungary, Israel, Italy, Latvia, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClinical Development
Opthea Ltd
Outcome results
None listed