Neovascular Age-related Macular Degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Eylea 40 mg/ml solution for injection in a vial
Product Name: Eylea
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Other descriptive n
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures 2. Men or women = 50 years old 3. Subjects must be diagnosed with neovascular (wet) AMD in the study eye (confirmed by central imaging vendor before randomization) 4. Active, treatment naïve CNV lesions secondary to neovascular (wet) AMD as confirmed with SD-OCT, FA and FP in the study eye (confirmed by central imaging vendor before randomization) 5. BCVA between 73 and 34 letters, inclusive, in the study eye using ETDRS testing 6. Presence of intra and/or subretinal fluid as identified by SD-OCT attributable to active CNV in the study eye (confirmed by central imaging vendor before randomization) 7. Central retinal thickness (CRT) of = 300 µm in the study eye as determined by SD-OCT at screening (confirmed by central imaging vendor before randomization) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 57 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 509
Exclusion criteria
Exclusion criteria: 1. Total lesion size > 9 disc areas (22.86 mm2, including blood, scars, and neovascularization) in the study eye (confirmed by central imaging vendor before randomization) 2. Active CNV area (classic plus occult components) that is < 50% of the total lesion area in the study eye (confirmed by central imaging vendor before randomization) 3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye (confirmed by central imaging vendor before randomization) 4. Presence of retinal pigment epithelium tears or rips involving the macula in the study eye (confirmed by central imaging vendor before randomization) 5. History of any vitreous hemorrhage within 4 weeks before randomization in the study eye 6. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of 8 diopters or more negative or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye (confirmed by central imaging vendor before randomization with the exception of the refractive error and axial length which is to be assessed by the investigator) 7. Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) in the study eye 8. History of retinal detachment in the study eye 9. Any history of macular hole of stage 2 and above in the study eye 10. Any macular pathology that might limit vision i.e., Vitreomacular traction or significant epiretinal membrane (confirmed by central imaging vendor before randomization) 11. Any intraocular or periocular surgery within 3 months before randomization on the study eye, except lid surgery, which may not have taken place within 4 weeks before randomization, as long as it is unlikely to interfere with the injection 12. Prior trabeculectomy or other filtration surgery in the study eye 13. Uncontrolled glaucoma (defined as intraocular pressure [IOP] = 25 mmHg despite treatment with antiglaucoma medication) in the study eye 14. Aphakia or pseudophakia with complete absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye 15. Previous therapeutic radiation in the region of the study eye 16. History of corneal transplant or corneal dystrophy in the study eye 17. Significant media opacities, including cataract, which might interfere with visual acuity or assessment of safety, in the study eye 18. Any concurrent intraocular condition other than neovascular (wet) AMD in the study eye that, in the opinion of the investigator, requires planned medical or surgical intervention during the study or increases the risk to the subject beyond what is expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety 19. History or clinical evidence of uveitis, diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than neovascular (wet) AMD (confirmed by central imaging vendor before randomization) 20. Active intraocular inflammation or active or suspected ocular or periocular infection, within 2 weeks before randomization 21. Active scleritis or episcleritis or presence of scleromalacia 22. Active extraocular infection or history of extraocular infections as follows: a. any active infection for which systemic anti-infectives were used w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of ABP 938 compared to aflibercept.;Secondary Objective: To assess the safety and immunogenicity of ABP 938 compared to aflibercept;Primary end point(s): Change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 8;Timepoint(s) of evaluation of this end point: week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects who maintained vision at week 52, where a subject was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score compared to baseline - Change from baseline in BCVA as measured by ETDRS letter score over the study duration - Proportion of subjects who gained at least 10 letters of vision at week 8 and proportion of subjects who gained at least 15 letters of vision at week 52 as compared to baseline - Change from baseline in choroidal neovascularization (CNV) area and central subfield thickness (CST) as measured by fluorescein angiography (FA) and spectral domain optical coherence tomography (SD OCT) over the study duration - Treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events - Incidence of antidrug antibodies (ADA);Timepoint(s) of evaluation of this end point: throughout the duration of the study | — |
Countries
Canada, Czech Republic, Estonia, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Latvia, Mexico, Poland, Serbia, Slovakia, Spain, United States
Contacts
Public ContactProject Leadership
Parexel International IRL Limited
Outcome results
None listed