Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

• Status: Completed
• Trial end date: 2020-06-04
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

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:

1. 50% or more of the total lesion area, or

2. if the blood was under the fovea, and

3. 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.