Trial Condition(s):
Diabetes Mellitus, Macular Edema
Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID-DME)
Bayer Identifier:
91745
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Darmstadt, Germany, 64297 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göttingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen, Germany, 67063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50924 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site München, Germany, 81675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aachen, Germany, 52074 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris, France, 75015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bordeaux, France, 33076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bytom, Poland, 41-902 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00198 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ancona, Italy, 60126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 77520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Faculty Hospital Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nedlands, Australia, 6009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parramatta, Australia, 2150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site East Melbourne, Australia, 3002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sydney, Australia, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Lariboisiere Paris, France, 75010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lyon, France, 69003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Århus C, Denmark, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glostrup, Denmark, 2600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 51-124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Cugat del Vallès, Spain, 08190 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alicante, Spain, 03016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pamplona, Spain, 31008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Asahikwa, Japan, 078-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Akita, Japan, 010-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Itabashi-ku, Japan, 173-8606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsumoto, Japan, 390-8621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 467-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 545-8586 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hirakata, Japan, 573-1191 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagasaki, Japan, 852-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1083 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zalaegerszeg, Hungary, H-8900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Veszprem, Hungary, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Westmead, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50-556 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 100 34 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES CEDEX, France, 44093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawasaki, Japan, 216-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CRETEIL CEDEX, France, 94010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wakayama, Japan, 641-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chiyoda-ku, Japan, 101-8309 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: Baseline up to Week 52
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 - LOCFVisual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.Timeframe: Baseline up to Week 52
- Percentage of participants who gained at least 15 letters in BCVA as measured by ETDRS letter score compared with baseline at Week 52 - LOCFVisual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.Timeframe: Baseline up to Week 52
- 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 - LOCFBaseline 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)Timeframe: Baseline up to Week 52
- Change from baseline in Central Retinal Thickness (CRT) at Week 52 as assessed on optical coherence tomography (OCT) - LOCFTimeframe: Baseline up to Week 52
- Change from baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) near activities subscale at Week 52 - LOCFThe 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.Timeframe: Baseline up to Week 52
- Change from baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) distance activities subscale at Week 52 - LOCFThe 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.Timeframe: Baseline up to Week 52
Additional Information
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