Phase 4
N=271
Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02581891 ↗Enrolled (actual)
271
Serious AEs
23.3%
Results posted
May 2020
Primary outcome: Primary: Change in BCVA as Measured by the ETDRS Letter Score — -2.1; -0.4 Letters correctly read — p=0.0162
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BCVA as Measured by the ETDRS Letter Score |
-2.1; -0.4 | 0.0162 sig |
| SECONDARY Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline |
93.4; 96.2 | — |
| SECONDARY Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52 |
7.8; 10.2; 4.3; 7.9; 66.7; 69.6 | — |
| SECONDARY Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline |
19.8; 27.9; 18.9; 22.1 | — |
| SECONDARY Change in Central Retinal Thickness (CRT) |
-164.9; -167.1; -161.6; -158.6; 321.4; 322.5 | — |
| SECONDARY Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104 |
7.1; 8.0; 12.0; 13.0 | — |
| SECONDARY Duration of Last Treatment Interval |
11.5; 11.4 | — |
| SECONDARY Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval |
5.7; 7.7; 27.4; 29.8; 19.8; 10.6 | — |
Summary
This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.
Eligibility Criteria
Inclusion Criteria
- Men and women ≥ 50 years of age.
- Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
- ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
- The area of CNV must occupy at least 50% of the total lesion.
Exclusion Criteria
- Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
- Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
- Prior treatment with anti-VEGF agents as follows:
- Prior treatment with anti-VEGF therapy in the study eye is not allowed
- Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
- Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
- Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
- Scar or fibrosis making up >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.
Data sourced from ClinicalTrials.gov (NCT02581891). 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.