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OpenTrials
Completed

NCT Number: NCT02540954

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

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)

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

51 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

A dose of 2 mg aflibercept injected intravitreally

Primary outcomes

  1. Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye

    Time frame: From baseline to Week 52

    Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.

Secondary outcomes

  1. Percentage of Participants Maintaining Vision in the Study Eye

    Time frame: At week 52

    A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.

  2. Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye

    Time frame: At week 52

  3. Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye

    Time frame: From baseline to week 52

    Retinal characteristic was evaluated using Optical coherence tomography (OCT).

  4. Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye

    Time frame: From baseline to week 52

    Choroidal neovascularization measured by optical coherence tomography (OCT).

  5. Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye

    Time frame: At week 52

  6. Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire

    Time frame: From baseline to week 52

    National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst.

  7. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    Time frame: Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Sep 4, 2015
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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