check_circleStudy Completed

Macular Degeneration

Efficacy and safety of two different aflibercept regimens in subjects with neovascular age-related macular degeneration (nAMD)

Trial purpose

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)

Key Participants Requirements

Sex

Both

Age

51 - N/A
  • - 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

  • - 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:
    a) 50% or more of the total lesion area, or
    b) if the blood was under the fovea, and
    c) 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.

Trial summary

Enrollment Goal
336
Trial Dates
September 2015 - June 2020
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Darmstadt, 64297, Germany
Completed
Göttingen, 37075, Germany
Completed
Frankfurt, 60596, Germany
Withdrawn
Mainz, 55131, Germany
Withdrawn
Dresden, 06067, Germany
Withdrawn
Dresden, 01307, Germany
Completed
Hamburg, 20251, Germany
Completed
Leipzig, 04103, Germany
Completed
Marburg, 35037, Germany
Withdrawn
PARIS, 75006, France
Completed
Dijon Cedex, BP 1542-21, France
Withdrawn
MARSEILLE, 13008, France
Completed
BORDEAUX, 33000, France
Withdrawn
TOULOUSE, 31200, France
Completed
Paris, 75557, France
Withdrawn
Lyon, 69003, France
Completed
LYON CEDEX 04, 69317, France
Completed
NICE CEDEX, 06006, France
Withdrawn
VILLEJUIF, 94800, France
Withdrawn
STRASBOURG, 67000, France
Completed
Clinique medicale de l'oeil de l'EstrieSherbrooke, J1J 2B8, Canada
Completed
Toronto, M4N 3M5, Canada
Withdrawn
Montreal, H3Z 1P4, Canada
Completed
Praha 10, 10034, Czechia
Completed
Hradec Kralove, 500 05, Czechia
Withdrawn
Usti n/Labem, 401 13, Czechia
Withdrawn
Wien, 1140, Austria
Completed
Wien, 1090, Austria
Completed
Berlin, 12203, Germany
Withdrawn
Berlin, 14450, Germany
Withdrawn
Tours, 37000, France
Completed
Barcelona, 8036, Spain
Completed
Barcelona, 08907, Spain
Withdrawn
Barcelona, 08035, Spain
Withdrawn
Albacete, 02006, Spain
Completed
Valencia, 46014, Spain
Completed
Budapest, 1085, Hungary
Withdrawn
Budapest, 1133, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Pecs, 7621, Hungary
Completed
Bratislava, 851 07, Slovakia
Completed
Nitra, 950 01, Slovakia
Completed
Bratislava, 826 06, Slovakia
Withdrawn
Ruzomberok, 03426, Slovakia
Completed
Southampton, SO16 6YD, United Kingdom
Withdrawn
Camberley, GU16 7UJ, United Kingdom
Completed
Guildford, GU2 7XX, United Kingdom
Completed
Sunderland, SR2 9HP, United Kingdom
Completed
London, SE5 9RS, United Kingdom
Completed
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Completed
London, NW1 5QH, United Kingdom
Completed
Manchester, M13 9WL, United Kingdom
Completed
Gdansk, 80-809, Poland
Withdrawn
Lublin, 20-081, Poland
Withdrawn
Krakow, 30 688, Poland
Withdrawn
Warszawa, 01-013, Poland
Completed
Genova, 16132, Italy
Completed
Torino, 10122, Italy
Withdrawn
Udine, 33100, Italy
Completed
Roma, 00133, Italy
Completed
Milano, 20122, Italy
Completed
Milano, 20132, Italy
Withdrawn
Brescia, 25123, Italy
Withdrawn
Padova, 35128, Italy
Completed
Verona, 37134, Italy
Completed
Milano, 20157, Italy
Completed
Roma, 00198, Italy
Withdrawn
Praha 4, 140 00, Czechia
Completed
Porto, 4200-319, Portugal
Completed
Leiria, 2410-197, Portugal
Completed
Lisboa, 1649-035, Portugal
Completed
Coimbra, 3000-548, Portugal
Completed
Coimbra, 3000-548, Portugal
Completed
Kaunas, LT-50009, Lithuania
Completed
Vilnius, LT-08661, Lithuania
Completed
Bern, Switzerland
Completed
Genève, 1204, Switzerland
Completed
Ottawa, K2B 7E9, Canada
Withdrawn
Warzawa, 01-364, Poland
Completed
Olsztyn, 10-424, Poland
Completed
Colchester, CO3 3NB, United Kingdom
Completed
Wurzburg, 97080, Germany
Withdrawn
Katowice, 40-514, Poland
Withdrawn
Warszawa, 03-709, Poland
Withdrawn
Köln, 50935, Germany
Completed
Paris, 75010, France
Completed
Liverpool, L7 8XP, United Kingdom
Completed
Praha 2, 12808, Czechia
Completed
Plzen, 32300, Czechia
Completed
Praha 5, 150 00, Czechia
Completed
Pisa, 56124, Italy
Withdrawn
Stuttgart, 70174, Germany
Withdrawn
Pavia, 27100, Italy
Completed
Brescia, 25015, Italy
Withdrawn
Bologna, 40138, Italy
Withdrawn
Varese, 21100, Italy
Withdrawn
Chieti, 66013, Italy
Completed
Parma, 43126, Italy
Completed
Berlin, 10713, Germany
Completed
Catania, 95123, Italy
Completed
Düsseldorf, 40225, Germany
Withdrawn
Bolton, BL4 0JR, United Kingdom
Completed
Wakefield, WF1 4DG, United Kingdom
Completed
Great Yarmouth, NR31 6LA, United Kingdom
Completed
Hull, HU3 2JZ, United Kingdom
Withdrawn
Kendal, LA9 7RG, United Kingdom
Withdrawn
Derby, DE22 3NE, United Kingdom
Completed
Middlesborough, TS43BW, United Kingdom
Withdrawn
Bury, BL9 7TD, United Kingdom
Withdrawn
Rhauderfehn, 26817, Germany
Completed
Pontyclun, CF72 8XR, United Kingdom
Completed
Rugby, CV22 5PX, United Kingdom
Withdrawn
Lisboa, 1500-650, Portugal
Withdrawn
MARSEILLE, 13285, France
Withdrawn
Warszawa, 01-755, Poland
Withdrawn
Firenze, 50134, Italy
Withdrawn
Dieppe, E1A 7R8, Canada

Primary Outcome

  • 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.
    date_rangeTime Frame:
    From baseline to Week 52

Secondary Outcome

  • 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.
    date_rangeTime Frame:
    At week 52
  • Percentage of participants who gained from baseline 5 or more letters in the study eye
    date_rangeTime Frame:
    At week 52
  • Mean change from baseline in Central retinal thickness (CRT) in the study eye
    Retinal characteristic was evaluated using Optical coherence tomography (OCT).
    date_rangeTime Frame:
    From baseline to week 52
  • Mean change from baseline in Choroidal neovascularization (CNV) area in the study eye
    Choroidal neovascularization measured by optical coherence tomography (OCT).
    date_rangeTime Frame:
    From baseline to week 52
  • Percentage of participants who lost from baseline 30 or more letters in the study eye
    date_rangeTime Frame:
    At week 52
  • 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.
    date_rangeTime Frame:
    From baseline to week 52
  • Number of participants with Treatment-emergent adverse events (TEAE)
    date_rangeTime 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

Trial design

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).
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2