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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Age-related macular degeneration (AMD), Eylea treatment, Treat and Extend, Intravitreal

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Clinique medicale de l'oeil de l'Estrie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aflibercept extended dosing

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

Arm 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).

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.

Outcomes

Primary Outcome Measures

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

Percentage of Participants Maintaining Vision in the Study Eye
A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Retinal characteristic was evaluated using Optical coherence tomography (OCT).
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye
Choroidal neovascularization measured by optical coherence tomography (OCT).
Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye
Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire
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.
Number of Participants With Treatment-emergent Adverse Events (TEAE)

Full Information

First Posted
September 2, 2015
Last Updated
June 1, 2021
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02540954
Brief Title
Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
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).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2015 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Age-related macular degeneration (AMD), Eylea treatment, Treat and Extend, Intravitreal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept extended dosing
Arm Type
Experimental
Arm 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).
Arm Title
Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention Description
A dose of 2 mg aflibercept injected intravitreally
Primary Outcome Measure Information:
Title
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye
Description
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.
Time Frame
From baseline to Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Maintaining Vision in the Study Eye
Description
A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Time Frame
At week 52
Title
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye
Time Frame
At week 52
Title
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Description
Retinal characteristic was evaluated using Optical coherence tomography (OCT).
Time Frame
From baseline to week 52
Title
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye
Description
Choroidal neovascularization measured by optical coherence tomography (OCT).
Time Frame
From baseline to week 52
Title
Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye
Time Frame
At week 52
Title
Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire
Description
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.
Time Frame
From baseline to week 52
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Wien
ZIP/Postal Code
1140
Country
Austria
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Clinique medicale de l'oeil de l'Estrie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2B8
Country
Canada
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
City
Paris
State/Province
Cedex 12
ZIP/Postal Code
75557
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Dijon Cedex
ZIP/Postal Code
BP 1542-21
Country
France
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
City
Nice Cedex
ZIP/Postal Code
06006
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64297
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Berlin
ZIP/Postal Code
10713
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00198
Country
Italy
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25015
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10122
Country
Italy
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
City
Parma
ZIP/Postal Code
43126
Country
Italy
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Gdansk
ZIP/Postal Code
80-809
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-424
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Bern
Country
Switzerland
City
Genève
ZIP/Postal Code
1204
Country
Switzerland
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
Great Yarmouth
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
City
Middlesborough
State/Province
North Yorkshire
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Pontyclun
State/Province
Rhondda, Cynon, Taff
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
City
Rugby
State/Province
Warwickshire
ZIP/Postal Code
CV22 5PX
Country
United Kingdom
City
Wakefield
State/Province
West Yorkshire
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
City
Hull
State/Province
York
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
City
Colchester
ZIP/Postal Code
CO3 3NB
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 5QH
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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