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Trial record 9 of 258 for:    macular degeneration | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Bayer
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02540954
First received: September 2, 2015
Last updated: November 15, 2016
Last verified: November 2016

September 2, 2015
November 15, 2016
September 2015
March 2019   (final data collection date for primary outcome measure)
Change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity (EDTRS BCVA) letter score for the study eye [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02540954 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Week 52 and Week 76 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects maintaining vision (i.e. loss of < 15 letters) in the study eye [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who gained from baseline ≥ 5 letters in the study eye [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean change from baseline in central retinal thickness (CRT) in the study eye [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean change from baseline in choroidal neovascularization (CNV) area in the study eye [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects who lost ≥ 30 letters [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean change from baseline in total score for National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
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).
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)
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Macular Degeneration
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
A dose of 2 mg aflibercept injected intravitreally
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
March 2019
March 2019   (final data collection date for primary outcome measure)

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.
Both
51 Years and older   (Adult, Senior)
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com
Austria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Lithuania,   Poland,   Portugal,   Slovakia,   Spain,   Switzerland,   United Kingdom
 
NCT02540954
16598, 2013-000120-33
No
Not Provided
Not Provided
Bayer
Bayer
Regeneron Pharmaceuticals
Study Director: Bayer Study Director Bayer
Bayer
November 2016

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