nAMD, Neovascular Age-related Macular Degeneration
Conditions
Keywords
ABP 938, Aflibercept, neovascular age-related macular degeneration, Intravitreal, Randomized Controlled Trial, Double-masked
Brief summary
The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)
Interventions
DRUGABP 938 8 mg
IVT injection
DRUGAflibercept (US) 8 mg
IVT injection
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women ≥ 50 years old, capable of giving signed informed consent * Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE) * Total area of CNV (including both classic and occult components) \> 50% of the total lesion area in the SE * The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE * Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol: * Total lesion size \> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye * Scar, fibrosis, or atrophy involving the central subfield in the study eye * Scar or fibrosis involving \> 50% of the total lesion in the study eye * Presence of retinal pigment epithelium tears or rips involving the macula in the study eye * History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study * Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study * Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye * History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye * Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization * Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening * Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins * History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score | Baseline and Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield, as Assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) | Week 16 |
| Change from Baseline in BCVA as measured by ETDRS letter score | Baseline to Week 48 |
| Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24 | Baseline to Week 24 |
| Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48 | Baseline to Week 48 |
| Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA) | Baseline to Week 48 |
| Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT | Baseline to Week 48 |
| Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments | Week 16 and Week 20 |
| Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 48 |
| Number of Participants Who Experienced Non-Ocular TEAEs | Baseline up to Week 48 |
| Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI) | Baseline up to Week 48 |
| Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Week 48 |
| Number of Participants Who Developed Binding Antidrug Antibodies (ADAs) | Baseline up to Week 48 |
| Free serum concentrations of ABP 938 8 mg | Week 16, week 24 and 48 (End of Study) |
| Free serum concentrations of Aflibercept (US) 8 mg | Week 16, week 24, and 48 (End of Study) |
| Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy | From Baseline (day 1, week 0) to Day 29 (pre dose week 4) |
| Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy | From Baseline (day 1, week 0) to Day 29 (pre dose week 4) |
Countries
Czechia, Japan, Latvia, Poland, Slovakia, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed