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).
2 other identifiers
interventional
336
14 countries
71
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2015
Longer than P75 for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedStudy Start
First participant enrolled
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2020
CompletedResults Posted
Study results publicly available
April 8, 2021
CompletedJune 11, 2021
June 1, 2021
4.2 years
September 2, 2015
December 21, 2020
June 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From baseline to Week 52
Secondary Outcomes (7)
Percentage of Participants Maintaining Vision in the Study Eye
At week 52
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye
At week 52
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
From baseline to week 52
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye
From baseline to week 52
Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye
At week 52
- +2 more secondary outcomes
Study Arms (2)
Aflibercept extended dosing
EXPERIMENTALAflibercept 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 2Q8 (2 mg aflibercept administered every 8 weeks)
ACTIVE COMPARATORAflibercept 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.
Interventions
A dose of 2 mg aflibercept injected intravitreally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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:
- % 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (71)
Unknown Facility
Vienna, 1090, Austria
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Vienna, 1140, Austria
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Toronto, Ontario, M4N 3M5, Canada
Clinique medicale de l'oeil de l'Estrie
Sherbrooke, Quebec, J1J 2B8, Canada
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Hradec KrĂ¡lovĂ©, 500 05, Czechia
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Pilsen, 304 60, Czechia
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Prague, 100 34, Czechia
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Prague, 12808, Czechia
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Prague, 150 00, Czechia
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Paris, Cedex 12, 75557, France
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Bordeaux, 33000, France
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Dijon, BP 1542-21, France
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Lyon, 69317, France
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Nice, 06006, France
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Paris, 75010, France
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WĂ¼rzburg, Bavaria, 97080, Germany
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Darmstadt, Hesse, 64297, Germany
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Frankfurt am Main, Hesse, 60596, Germany
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Marburg, Hesse, 35037, Germany
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Göttingen, Lower Saxony, 37075, Germany
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DĂ¼sseldorf, North Rhine-Westphalia, 40225, Germany
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Leipzig, Saxony, 04103, Germany
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Berlin, 10713, Germany
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Berlin, 12203, Germany
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Hamburg, 20251, Germany
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Budapest, 1085, Hungary
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Debrecen, 4032, Hungary
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PĂ©cs, 7621, Hungary
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Rome, Lazio, 00133, Italy
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Rome, Lazio, 00198, Italy
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Genoa, Liguria, 16132, Italy
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Brescia, Lombardy, 25015, Italy
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Milan, Lombardy, 20122, Italy
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Milan, Lombardy, 20132, Italy
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Milan, Lombardy, 20157, Italy
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Turin, Piedmont, 10122, Italy
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Catania, Sicily, 95123, Italy
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Pisa, Tuscany, 56124, Italy
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Verona, Veneto, 37134, Italy
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Parma, 43126, Italy
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Kaunas, LT-50009, Lithuania
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Vilnius, LT-08661, Lithuania
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Gdansk, 80-809, Poland
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Olsztyn, 10-424, Poland
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Coimbra, 3000-548, Portugal
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Leiria, 2410-197, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4200-319, Portugal
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Bratislava, 826 06, Slovakia
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Bratislava, 851 07, Slovakia
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Nitra, 949 01, Slovakia
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Barcelona, 08036, Spain
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Valencia, 46014, Spain
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Bern, Switzerland
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Geneva, 1204, Switzerland
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Southampton, Hampshire, SO16 6YD, United Kingdom
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Liverpool, Merseyside, L7 8XP, United Kingdom
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Great Yarmouth, Norfolk, NR31 6LA, United Kingdom
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Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom
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Pont-y-clun, Rhondda, Cynon, Taff, CF72 8XR, United Kingdom
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Guildford, Surrey, GU2 7XX, United Kingdom
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Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
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Sunderland, Tyne and Wear, SR2 9HP, United Kingdom
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Rugby, Warwickshire, CV22 5PX, United Kingdom
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Wakefield, West Yorkshire, WF1 4DG, United Kingdom
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Hull, York, HU3 2JZ, United Kingdom
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Colchester, CO3 3NB, United Kingdom
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London, NW1 5QH, United Kingdom
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London, SE5 9RS, United Kingdom
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Manchester, M13 9WL, United Kingdom
Related Publications (1)
Kodjikian L, Arias Barquet L, Papp A, Kertes PJ, Midena E, Ernest J, Silva R, Schmelter T, Niesen T, Leal S. Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration Beyond One Year of Treatment: AZURE, a Randomized Trial of Treat-and-Extend vs. Fixed Dosing. Adv Ther. 2024 Mar;41(3):1010-1024. doi: 10.1007/s12325-023-02719-3. Epub 2024 Jan 6.
PMID: 38183525DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 4, 2015
Study Start
September 29, 2015
Primary Completion
December 24, 2019
Study Completion
June 4, 2020
Last Updated
June 11, 2021
Results First Posted
April 8, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
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.