check_circleStudy Completed

Macular edema

Bayer Identifier:

17850

ClinicalTrials.gov Identifier:

NCT02581995

EudraCT Number:

2014-005119-17

EU CT Number:

Not Available
Investigation of the change of vision-related quality of life in subjects treated with aflibercept according to EU label for DME.

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.)

  • - Pregnancy and lactation
    - Mismatch with inclusion criteria

Trial summary

Enrollment Goal
560
Trial Dates
November 2015 - August 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praha 10, 100 34, Czech Republic
Completed
Hradec Kralove, 500 05, Czech Republic
Withdrawn
Nottingham, NG7 2UH, United Kingdom
Completed
Southampton, SO16 6YD, United Kingdom
Completed
Camberley, GU16 7UJ, United Kingdom
Withdrawn
PARIS, 75006, France
Withdrawn
Dijon Cedex, BP 1542-21, France
Withdrawn
MARSEILLE, 13008, France
Withdrawn
BORDEAUX, 33000, France
Withdrawn
TOULOUSE, 31200, France
Withdrawn
Paris, 75557, France
Withdrawn
Lyon, 69003, France
Withdrawn
LYON, 69004, France
Completed
Budapest, 1083, Hungary
Completed
Budapest, 1133, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Pecs, 7621, Hungary
Completed
Budapest, 1106, Hungary
Completed
Zvolen, 960 01, Slovakia
Completed
Bratislava, 85107, Slovakia
Completed
Guildford, GU2 7XX, United Kingdom
Completed
Sunderland, SR2 9HP, United Kingdom
Completed
Leeds, LS9 7TF, United Kingdom
Completed
London, EC1V 2PD, United Kingdom
Completed
Barcelona, 08036, Spain
Completed
L'Hospitalet de Llobregat, 08907, Spain
Completed
Barcelona, 08035, Spain
Completed
Albacete, 02006, Spain
Completed
Valencia, 46014, Spain
Completed
San Cugat del Vallès, 08190, Spain
Completed
Nitra, 949 01, Slovakia
Completed
Bratislava, 826 06, Slovakia
Completed
Darmstadt, 64276, Germany
Completed
Köln, 50937, Germany
Completed
Göttingen, 37099, Germany
Completed
Frankfurt, 60596, Germany
Completed
Mainz, 55131, Germany
Completed
Dresden, 01067, Germany
Completed
Dresden, 01307, Germany
Withdrawn
Hamburg, 20246, Germany
Completed
Leipzig, 04103, Germany
Completed
Bonn, 53105, Germany
Withdrawn
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Withdrawn
NICE CEDEX, 06006, France
Withdrawn
VILLEJUIF, 94800, France
Completed
CRETEIL CEDEX, 94010, France
Completed
Genova, 16132, Italy
Completed
Sassari, 07100, Italy
Completed
Torino, 10122, Italy
Withdrawn
Udine, 33100, Italy
Completed
Roma, 00133, Italy
Completed
Milano, 20122, Italy
Completed
Firenze, 50134, Italy
Withdrawn
NIJMEGEN, 6525 GA, Netherlands
Completed
Kaunas, LT-50009, Lithuania
Completed
Vilnius, LT-08661, Lithuania
Completed
Newcastle Upon Tyne, NE1 4LP, United Kingdom
Withdrawn
STRASBOURG, 67000, France
Completed
Milano, 20132, Italy
Completed
Cagliari, 09124, Italy
Withdrawn
Brescia, 25123, Italy
Withdrawn
ROTTERDAM, 3011 BH, Netherlands
Withdrawn
TILBURG, 5022 GC, Netherlands
Withdrawn
London, NW1 5QH, United Kingdom
Completed
Gdansk, 80-809, Poland
Completed
Lublin, 20-079, Poland
Completed
Padova, 35128, Italy
Completed
Sherbrooke, J1G 2V4, Canada
Completed
London, N6A 4V2, Canada
Withdrawn
Toronto, M4N 3M5, Canada
Withdrawn
Montreal, H3Z 1P4, Canada
Withdrawn
Toronto, M5T 2S8, Canada
Completed
Montreal, H4P 2S4, Canada
Withdrawn
Verona, 37126, Italy
Completed
Halifax, B3H 2Y9, Canada
Completed
Usti nad Labem, 401 13, Czech Republic
Completed
Porto, 4200-319, Portugal
Completed
Wien, 1140, Austria
Completed
Wien, 1090, Austria
Completed
Graz, 8036, Austria
Completed
Marburg, 35043, Germany
Completed
Ludwigshafen, 67063, Germany
Withdrawn
Bochum, 44892, Germany
Withdrawn
Toronto, M5C 2T2, Canada
Completed
Toronto, M3C 0G9, Canada
Completed
Ottawa, K1H 8L6, Canada
Completed
Mississauga, L4W 1W9, Canada
Withdrawn
Berlin, 12203, Germany
Withdrawn
Wroclaw, 51-124, Poland
Completed
Krakow, 31-501, Poland
Completed
Bydgoszcz, 85-631, Poland
Completed
Leiria, 2410-197, Portugal
Completed
Lisboa, 1649-035, Portugal
Completed
Vila Franca de Xira, 2600-178, Portugal
Completed
Coimbra, 3000-548, Portugal
Withdrawn
Ruzomberok, 03426, Slovakia
Completed
Bern, Switzerland
Withdrawn
Berlin, 14450, Germany
Withdrawn
Tours, 37000, France
Completed
Warszawa, 01-013, Poland
Completed
Poznan, 61-285, Poland
Withdrawn
HILVERSUM, 1217 ET, Netherlands
Withdrawn
Manchester, M13 9WL, United Kingdom
Completed
Warszawa, 04-141, Poland
Completed
Lodz, 91-134, Poland
Completed
Katowice, 40-594, Poland
Completed
Genève, 1204, Switzerland
Withdrawn
Porto, 4200-319, Portugal
Withdrawn
Coimbra, 3000-548, Portugal
Withdrawn
Milano, 20157, Italy
Withdrawn
Roma, 00198, Italy
Withdrawn
Praha 4, 140 00, Czech Republic
Completed
MARSEILLE, 13285, France
Withdrawn
Ottawa, K2B 7E9, Canada
Withdrawn
Mühlheim, 45468, Germany
Withdrawn
Würzburg, 97080, Germany
Completed
Zilina, 01207, Slovakia

Primary Outcome

  • Change from baseline to week 52 in NEI VFQ 25 total score
    National 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.
    date_rangeTime Frame:
    Baseline, Week 52
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change from Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale
    NEI 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.
    date_rangeTime Frame:
    Baseline, Week 52
    enhanced_encryption
    Safety Issue:
    No
  • Change from Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale
    NEI 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.
    date_rangeTime Frame:
    Baseline, Week 52
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline, Week 52
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline, Week 52
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline, Week 52
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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