Phase 3
N=576
A Study to Understand Effectiveness and Safety of ABP 938 Compared to Aflibercept (Eylea®) in Patients Suffering With Neovascular Age-related Macular Degeneration [Neovascular (Wet) AMD]
Neovascular (Wet) Age-related Macular Degeneration (AMD)
Bottom Line
View on ClinicalTrials.gov: NCT04270747 ↗Enrolled (actual)
576
Serious AEs
5.6%
Results posted
Jan 2024
Primary outcome: Primary: Mean Change From Baseline in BCVA at Week 8 — 6.4; 6.5 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABP 938 (Drug); Aflibercept (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in BCVA at Week 8 |
6.4; 6.5 | — |
| SECONDARY Percentage of Participants Who Maintained Vision at Week 52 |
95.6; 97.6; 95.9 | — |
| SECONDARY Mean Change From Baseline in BCVA |
5.0; 5.4; 3.8; 6.5; 7.6; 5.6 | — |
| SECONDARY Percentage of Participants Who Gained at Least 10 Letters of Vision at Week 8 |
29.4; 32.7 | — |
| SECONDARY Percentage of Participants Who Gained at Least 15 Letters of Vision at Week 52 |
24.3; 29.6; 24.4 | — |
| SECONDARY Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size |
-4.962; -5.479; -5.169; -4.089; -5.174; -4.751 | — |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness (CST) |
-136.5; -143.1; -149.7; -145.9; -146.3; -167.4 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
113; 107; 144; 76; 72; 6 | — |
| SECONDARY Number of Participants Developing Binding Antidrug Antibodies (ADAs) |
1; 4; 4; 3; 0 | — |
Summary
The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.
Eligibility Criteria
Inclusion Criteria
- Subjects or their legally authorized representative must sign an Institutional Review Board/Independent Ethics Committee approved informed consent form before any study-specific procedures
- Men or women ≥ 50 years old
- Subjects must be diagnosed with neovascular (wet) AMD in the study eye
- Active treatment naïve subfoveal CNV lesions secondary to neovascular (wet) AMD including juxtafoveal lesions that affect the fovea as confirmed with SD OCT, FA and/or Fundus Photography (FP) in the study eye
- BCVA between 73 and 34 letters, inclusive, in the study eye using ETDRS testing
- Presence of intra and/or subretinal fluid as identified by SD-OCT attributable to active CNV in the study eye
- Central retinal thickness of > 270µm in the study eye as measured by the machine, calculated average thickness in the central 1 mm subfield (CST) by SD-OCT at screening
Exclusion Criteria
Subjects are excluded if they meet any of the following criteria in the study eye:
- Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars, and neovascularization) in the study eye
- Active CNV area (classic plus occult components) that is < 50% of the total lesion area in the study eye
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
- History of any vitreous hemorrhage within 4 weeks before randomization in the study eye
- 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
- Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) in the study eye
- History of retinal detachment in the study eye
- Any history of macular hole of stage 2 and above in the study eye
- Any macular pathology that might limit vision i.e., Vitreomacular traction or significant epiretinal membrane in the study eye
- 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
- Prior trabeculectomy or other filtration surgery in the study eye
- Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye
- 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
- Previous therapeutic radiation in the region of the study eye
- History of corneal transplant or corneal dystrophy in the study eye
- Significant media opacities, including cataract, which might interfere with visual acuity or assessment of safety, in the study eye
- 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
Subjects are excluded if they meet any of the following criteria in either eye:
- History or clinical evidence of uveitis, diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than neovascular (wet) AMD
- Active intraocular inflammation or active or suspected ocular or periocular infection, within 2 weeks before randomization
- Active scleritis or episcleritis or presence of scleromalacia
Other Medical Conditions
- Active extraocular infection or history of extraocular infections as follows: A. any active infection for wh
Data sourced from ClinicalTrials.gov (NCT04270747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.