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 | Status | |
|---|---|---|
Locations Investigative Site Praha 10, Czech Republic, 100 34 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Hradec Kralove, Czech Republic, 500 05 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Southampton, United Kingdom, SO16 6YD | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Camberley, United Kingdom, GU16 7UJ | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Budapest, Hungary, 1083 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Budapest, Hungary, 1133 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Pecs, Hungary, 7621 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Budapest, Hungary, 1106 | Status Completed | Contact Us: E-mail: clinical-t[email protected] Phone: +49 30 300139003 |
Locations Investigative Site Zvolen, Slovakia, 960 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bratislava, Slovakia, 85107 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Guildford, United Kingdom, GU2 7XX | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sunderland, United Kingdom, SR2 9HP | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site London, United Kingdom, EC1V 2PD | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Albacete, Spain, 02006 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site San Cugat del Vallès, Spain, 08190 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Nitra, Slovakia, 949 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bratislava, Slovakia, 826 06 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Darmstadt, Germany, 64276 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Köln, Germany, 50937 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Göttingen, Germany, 37099 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Frankfurt, Germany, 60596 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Dresden, Germany, 01067 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bonn, Germany, 53105 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site CRETEIL CEDEX, France, 94010 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Torino, Italy, 10122 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Roma, Italy, 00133 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Firenze, Italy, 50134 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kaunas, Lithuania, LT-50009 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE1 4LP | Status Completed | Contact Us: E-mail: [email protected]r.com Phone: +49 30 300139003 |
Locations Investigative Site Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Cagliari, Italy, 09124 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Gdansk, Poland, 80-809 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Lublin, Poland, 20-079 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sherbrooke, Canada, J1G 2V4 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site London, Canada, N6A 4V2 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Montreal, Canada, H4P 2S4 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Halifax, Canada, B3H 2Y9 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Usti nad Labem, Czech Republic, 401 13 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Porto, Portugal, 4200-319 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Wien, Austria, 1140 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Marburg, Germany, 35043 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Ludwigshafen, Germany, 67063 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Toronto, Canada, M3C 0G9 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Mississauga, Canada, L4W 1W9 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Krakow, Poland, 31-501 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bydgoszcz, Poland, 85-631 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Leiria, Portugal, 2410-197 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Lisboa, Portugal, 1649-035 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Vila Franca de Xira, Portugal, 2600-178 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Coimbra, Portugal, 3000-548 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bern, Switzerland | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Warszawa, Poland, 01-013 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Poznan, Poland, 61-285 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Warszawa, Poland, 04-141 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Lodz, Poland, 91-134 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Katowice, Poland, 40-594 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Genève, Switzerland, 1204 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site MARSEILLE, France, 13285 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Zilina, Slovakia, 01207 | Status Completed | 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
Copyright © Bayer
Powered by
