check_circleStudy Completed
Macular Degeneration
Bayer Identifier:
16598
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
BothAge
51 - N/ATrial summary
Enrollment Goal
336Trial Dates
September 2015 - June 2020Phase
Phase 3Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Mainz, 55131, Germany | |
Withdrawn | Dresden, 06067, Germany | |
Withdrawn | Dresden, 01307, Germany | |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Withdrawn | PARIS, 75006, France | |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Withdrawn | MARSEILLE, 13008, France | |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Withdrawn | TOULOUSE, 31200, France | |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Withdrawn | Lyon, 69003, France | |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Withdrawn | VILLEJUIF, 94800, France | |
Withdrawn | STRASBOURG, 67000, France | |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'Estrie | Sherbrooke, 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Withdrawn | Montreal, H3Z 1P4, Canada | |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Withdrawn | Usti n/Labem, 401 13, Czechia | |
Withdrawn | Wien, 1140, Austria | |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Withdrawn | Berlin, 14450, Germany | |
Withdrawn | Tours, 37000, France | |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Withdrawn | Barcelona, 08035, Spain | |
Withdrawn | Albacete, 02006, Spain | |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Withdrawn | Budapest, 1133, Hungary | |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 eyeVisual 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 eyeA 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 eyedate_rangeTime Frame:At week 52
- Mean change from baseline in Central retinal thickness (CRT) in the study eyeRetinal 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 eyeChoroidal 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 eyedate_rangeTime Frame:At week 52
- Mean change from baseline in total score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) QuestionnaireNational 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2