check_circleStudy Completed

Diabetes Mellitus, Macular Edema

Bayer Identifier:

91745

ClinicalTrials.gov Identifier:

NCT01331681

EudraCT Number:

2010-022364-12

EU CT Number:

Not Available
Intravitreal Aflibercept Injection in Vision Impairment Due to DME

Trial purpose

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Adults ≥ 18 years with type 1 or 2 diabetes mellitus
    - Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye
    - Decrease in vision determined to be primarily the result of DME in the study eye
    - BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
  • - Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
    - More than 2 previous macular laser treatments in the study eye
    - Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
    - Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
    - Active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
    - Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
    - Only 1 functional eye even if that eye is otherwise eligible for the study

Trial summary

Enrollment Goal
406
Trial Dates
May 2011 - March 2015
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
Kiel, 24105, Germany
Completed
Darmstadt, 64297, Germany
Completed
Göttingen, 37075, Germany
Completed
Freiburg, 79106, Germany
Completed
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Completed
Köln, 50924, Germany
Completed
Bonn, 53105, Germany
Withdrawn
Leipzig, 04103, Germany
Withdrawn
Mannheim, 68167, Germany
Completed
Tübingen, 72076, Germany
Completed
München, 81675, Germany
Completed
Aachen, 52074, Germany
Completed
Heidelberg, 69120, Germany
Withdrawn
Dresden, 06067, Germany
Completed
Paris, 75015, France
Completed
Bordeaux, 33076, France
Withdrawn
MARSEILLE, 13008, France
Completed
Bytom, 41-902, Poland
Withdrawn
Bialystok, 15-276, Poland
Completed
Padova, 35128, Italy
Completed
Roma, 00198, Italy
Completed
Ancona, 60126, Italy
Completed
IRCCS Fondazione Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
Roma, 00133, Italy
Completed
Santiago de Compostela, 15706, Spain
Completed
Oviedo, 33012, Spain
Completed
Valencia, 46015, Spain
Completed
Ostrava, 708 52, Czechia
Completed
Olomouc, 779 00, Czechia
Completed
Faculty Hospital Hradec KraloveHradec Kralove, 500 05, Czech Republic
Withdrawn
Chatswood, 2067, Australia
Completed
Nedlands, 6009, Australia
Completed
Parramatta, 2150, Australia
Completed
East Melbourne, 3002, Australia
Completed
Sydney, 2000, Australia
Withdrawn
Prahran, Australia
Completed
Linz, 4021, Austria
Completed
Wien, 1090, Austria
Completed
Linz, 4020, Austria
Withdrawn
Zlin, 760 01, Czechia
Completed
Hopital LariboisiereParis, 75010, France
Completed
Lyon, 69003, France
Completed
Milano, 20157, Italy
Completed
Århus C, 8000, Denmark
Withdrawn
Odense C, 5000, Denmark
Completed
Glostrup, 2600, Denmark
Completed
Wroclaw, 51-124, Poland
Completed
San Cugat del Vallès, 08190, Spain
Completed
Alicante, 03016, Spain
Completed
Pamplona, 31008, Spain
Completed
Barcelona, 8036, Spain
Completed
Mainz, 55131, Germany
Completed
Asahikwa, 078-8510, Japan
Completed
Sapporo, 060-8648, Japan
Completed
Akita, 010-8543, Japan
Completed
Sendai, 980-8574, Japan
Completed
Shinjuku-ku, 162-8666, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Itabashi-ku, 173-8606, Japan
Completed
Chiba, 260-8677, Japan
Completed
Matsumoto, 390-8621, Japan
Completed
Nagoya, 467-8602, Japan
Completed
Nagoya, 466-8560, Japan
Completed
Osaka, 545-8586, Japan
Completed
Hirakata, 573-1191, Japan
Completed
Fukuoka, 812-8582, Japan
Completed
Nagasaki, 852-8501, Japan
Completed
Budapest, 1106, Hungary
Completed
Budapest, 1133, Hungary
Completed
Budapest, 1083, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Zalaegerszeg, H-8900, Hungary
Completed
Veszprem, 8200, Hungary
Completed
Westmead, 2145, Australia
Completed
Wroclaw, 50-556, Poland
Completed
Praha 10, 100 34, Czechia
Completed
Berlin, 12203, Germany
Completed
NANTES CEDEX, 44093, France
Completed
Kawasaki, 216-8511, Japan
Completed
CRETEIL CEDEX, 94010, France
Withdrawn
Taipei, Taiwan
Withdrawn
Kaohsiung, 81362, Taiwan
Withdrawn
Changhua City, 500, Taiwan
Withdrawn
Chemnitz, 09116, Germany
Withdrawn
Bonn, 53105, Germany
Withdrawn
Yufu, 879-5593, Japan
Completed
Wakayama, 641-8510, Japan
Completed
Chiyoda-ku, 101-8309, Japan
Withdrawn
Bochum, 44892, Germany
Withdrawn
Münster, 48145, Germany
Withdrawn
PARIS, 75006, France

Primary Outcome

  • Change from baseline in BCVA (best corrected visual acuity) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 52 - Last observation carried forward (LOCF)
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of participants who gained at least 10 letters in BCVA as measured by ETDRS letter score compared with baseline at Week 52 - LOCF
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants who gained at least 15 letters in BCVA as measured by ETDRS letter score compared with baseline at Week 52 - LOCF
    Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with a ≥2-step improvement from baseline in the ETDRS DRSS (diabetic retinopathy severity score) as assessed by FP (fundus photography) at Week 52 - LOCF
    Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Central Retinal Thickness (CRT) at Week 52 as assessed on optical coherence tomography (OCT) - LOCF
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) near activities subscale at Week 52 - LOCF
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) distance activities subscale at Week 52 - LOCF
    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
    date_rangeTime Frame:
    Baseline up to Week 52
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, double masked, active controlled, phase III study of the efficacy and safety of repeated doses of intravitreal VEGF Trap-Eye in subjects with diabetic macular edema
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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