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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540954
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE September 4, 2015
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE September 29, 2015
Actual Primary Completion Date December 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
Change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity (EDTRS BCVA) letter score for the study eye [ Time Frame: Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
  • Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Week 52 and Week 76 ]
  • Proportion of subjects maintaining vision (i.e. loss of < 15 letters) in the study eye [ Time Frame: Week 52 ]
  • Proportion of subjects who gained from baseline ≥ 5 letters in the study eye [ Time Frame: Week 52 ]
  • Mean change from baseline in central retinal thickness (CRT) in the study eye [ Time Frame: Week 52 ]
  • Mean change from baseline in choroidal neovascularization (CNV) area in the study eye [ Time Frame: Week 52 ]
  • Proportion of subjects who lost ≥ 30 letters [ Time Frame: Week 52 ]
  • Mean change from baseline in total score for National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Official Title  ICMJE 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).
Brief 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)
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
A dose of 2 mg aflibercept injected intravitreally
Study Arms  ICMJE
  • Experimental: Flexible dosing intervals
    Flexible dosing intervals: 2 mg aflibercept (Eylea) injected intravitreally with flexible injection intervals (more than 8 weeks)
    Intervention: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
  • Experimental: Fixed injection intervals
    2 mg aflibercept (Eylea) injected intravitreally with fixed injection intervals (8 weeks ±7 days)
    Intervention: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2020)
336
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2015)
330
Actual Study Completion Date  ICMJE June 4, 2020
Actual Primary Completion Date December 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 51 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Portugal,   Slovakia,   Spain,   Switzerland,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02540954
Other Study ID Numbers  ICMJE 16598
2013-000120-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP