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Trial record 11 of 231 for:    macular degeneration | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02540954
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

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)

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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).
Actual Study Start Date : September 29, 2015
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : January 12, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Flexible dosing intervals
Flexible dosing intervals: 2 mg aflibercept (Eylea) injected intravitreally with flexible injection intervals (more than 8 weeks)
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
A dose of 2 mg aflibercept injected intravitreally
Experimental: Fixed injection intervals
2 mg aflibercept (Eylea) injected intravitreally with fixed injection intervals (8 weeks ±7 days)
Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
A dose of 2 mg aflibercept injected intravitreally



Primary Outcome Measures :
  1. Change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity (EDTRS BCVA) letter score for the study eye [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Week 52 and Week 76 ]
  2. Proportion of subjects maintaining vision (i.e. loss of < 15 letters) in the study eye [ Time Frame: Week 52 ]
  3. Proportion of subjects who gained from baseline ≥ 5 letters in the study eye [ Time Frame: Week 52 ]
  4. Mean change from baseline in central retinal thickness (CRT) in the study eye [ Time Frame: Week 52 ]
  5. Mean change from baseline in choroidal neovascularization (CNV) area in the study eye [ Time Frame: Week 52 ]
  6. Proportion of subjects who lost ≥ 30 letters [ Time Frame: Week 52 ]
  7. Mean change from baseline in total score for National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540954


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

  Show 114 Study Locations
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02540954     History of Changes
Other Study ID Numbers: 16598
2013-000120-33 ( EudraCT Number )
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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

Keywords provided by Bayer:
Age-related macular degeneration (AMD)
Eylea treatment
Treat and Extend
Intravitreal

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases