Trial Condition(s):
Macular Edema
Investigation of the change of vision-related quality of life in subjects treated with aflibercept according to EU label for DME. (AQUA)
Bayer Identifier:
17850
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.
Inclusion Criteria
- Type 1 or 2 diabetes mellitus - Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye - Decrease in vision determined to be primarily the result of DME in the study eye - BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Exclusion Criteria
- Pregnancy and lactation - Mismatch with inclusion criteria
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 Praha 10, Czech Republic, 100 34 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Southampton, United Kingdom, SO16 6YD | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Camberley, United Kingdom, GU16 7UJ | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Budapest, Hungary, 1083 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Budapest, Hungary, 1133 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Pecs, Hungary, 7621 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Budapest, Hungary, 1106 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Zvolen, Slovakia, 960 01 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bratislava, Slovakia, 85107 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Guildford, United Kingdom, GU2 7XX | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sunderland, United Kingdom, SR2 9HP | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site London, United Kingdom, EC1V 2PD | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Albacete, Spain, 02006 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site San Cugat del Vallès, Spain, 08190 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Nitra, Slovakia, 949 01 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bratislava, Slovakia, 826 06 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Darmstadt, Germany, 64276 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Göttingen, Germany, 37099 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Dresden, Germany, 01067 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site CRETEIL CEDEX, France, 94010 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sassari, Italy, 07100 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Torino, Italy, 10122 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Roma, Italy, 00133 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE1 4LP | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Cagliari, Italy, 09124 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Gdansk, Poland, 80-809 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Lublin, Poland, 20-079 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sherbrooke, Canada, J1G 2V4 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site London, Canada, N6A 4V2 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Montreal, Canada, H4P 2S4 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Halifax, Canada, B3H 2Y9 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Usti nad Labem, Czech Republic, 401 13 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Wien, Austria, 1140 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Marburg, Germany, 35043 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Ludwigshafen, Germany, 67063 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Toronto, Canada, M3C 0G9 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Mississauga, Canada, L4W 1W9 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Krakow, Poland, 31-501 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bydgoszcz, Poland, 85-631 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leiria, Portugal, 2410-197 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Vila Franca de Xira, Portugal, 2600-178 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Coimbra, Portugal, 3000-548 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bern, Switzerland | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Warszawa, Poland, 01-013 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Poznan, Poland, 61-285 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Lodz, Poland, 91-134 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Katowice, Poland, 40-594 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Genève, Switzerland, 1204 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site MARSEILLE, France, 13285 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Zilina, Slovakia, 01207 | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Open-label Phase-4 study to examine the change of vision-related quality of life in subjects with diabetic macular edema (DME) during treatment with intravitreal injections of 2 mg aflibercept according to EU label for the first year of treatment
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Change from baseline to week 52 in NEI VFQ 25 total scoreNational eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the “NEI VFQ-25 Scoring Algorithm – August 2000”. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.Timeframe: Baseline, Week 52
Secondary Outcome
- Change from Baseline to Week 52 in the NEI VFQ 25 Near Activities SubscaleNEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the “NEI VFQ-25 Scoring Algorithm – August 2000”. Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered.Timeframe: Baseline, Week 52
- Change from Baseline to Week 52 in the NEI VFQ 25 Distant Activities SubscaleNEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the “NEI VFQ-25 Scoring Algorithm – August 2000”. Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered.Timeframe: Baseline, Week 52
- Change from Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] letter score])Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group 1985) starting at 4 meters. The values might range from 0 to 100. A higher score represents better functioning.Timeframe: Baseline, Week 52
- Change from Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT). For all visits where the OCT procedure was scheduled, images were captured and read by the investigator. All OCTs were electronically archived at the study sites as part of the source documentation.Timeframe: Baseline, Week 52
- Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP)The ETDRS DRSS was assessed by FP according to the following scale for both eyes. The following severities are possible. 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.Timeframe: Baseline, Week 52
Additional Information
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