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

Bayer

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

Treatments: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02540954

2013-000120-33 (EudraCT Number)

16598

Details and patient eligibility

About

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)

Full description

330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.

Enrollment: 336 patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

Aflibercept extended dosing

Experimental group

Description:

Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).

Treatment:

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks)

Active Comparator group

Description:

Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.

Treatment:

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)