Phase 3
N=336
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02540954 ↗Enrolled (actual)
336
Serious AEs
14.6%
Results posted
Apr 2021
Primary outcome: Primary: Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye — -0.3; -0.5 Letters read correctly — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
- Age
- Adult, Older Adult · 51+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye |
-0.3; -0.5 | < 0.0001 sig |
| SECONDARY Percentage of Participants Maintaining Vision in the Study Eye |
95.2; 94.0 | — |
| SECONDARY Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye |
24.2; 21.0 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye |
-24.4; -33.4 | — |
| SECONDARY Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye |
0.274; 0.204 | — |
| SECONDARY Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye |
0; 0.6 | — |
| SECONDARY Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire |
0.186; -1.694 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAE) |
130; 124; 26; 23 | — |
Summary
To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)
Eligibility Criteria
Inclusion Criteria
- The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study):
- Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment.
- The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
- Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment.
- Men and women >= 51 years of age
- The subject's history of aflibercept treatment meets ALL of the following:
- Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
- Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks
Exclusion Criteria
- Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.
- Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
- Subretinal hemorrhage that was:
- 50% or more of the total lesion area, or
- if the blood was under the fovea, and
- the blood under the fovea was 1 or more disc areas in size in the study eye.
- Scar or fibrosis making up more than 50% of the total lesion in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- Causes of CNV other than AMD in the study eye.
Data sourced from ClinicalTrials.gov (NCT02540954). 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.