Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.

NCT02581995 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 178502014-005119-17
• Study Type: interventional
• Target: 560
• Locations: 14 countries
• Sites: 76

Brief Summary

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.

Conditions

Macular Edema

Keywords

Diabetic macular edema; Intravitreal injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 52

Secondary Outcomes (5)

• Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale

  Baseline, Week 52

• Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale

  Baseline, Week 52

• Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score])

  Baseline, Week 52

• Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)

  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)

  Baseline, Week 52

Other Outcomes (5)

• Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks

  Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52

• Change From Baseline in Systolic Blood Pressure at Week 52

  Baseline, Week 52

• Change From Baseline in Diastolic Blood Pressure at Week 52

  Baseline, Week 52

Study Arms (1)

Arm 1 / Quality of Life

EXPERIMENTAL

Aflibercept treatment in subjects with diabetic macular edema (DME)

Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Interventions

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) DRUG

2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection

Arm 1 / Quality of Life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• Pregnancy and lactation

Sponsors & Collaborators

• Bayer: lead

Study Sites (76)

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Graz, Styria, 8036, Austria

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Vienna, 1090, Austria

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Vienna, 1140, Austria

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 4V2, Canada

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Mississauga, Ontario, L4W 1W9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M3C 0G9, Canada

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Montreal, Quebec, H4P 2S4, Canada

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Sherbrooke, Quebec, J1G 2V4, Canada

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Hradec Králové, 500 05, Czechia

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Prague, 100 34, Czechia

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Ústí nad Labem, 401 13, Czechia

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Créteil, 94010, France

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Marseille, 13285, France

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Darmstadt, Hesse, 64276, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Marburg, Hesse, 35043, Germany

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Göttingen, Lower Saxony, 37099, Germany

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Bonn, North Rhine-Westphalia, 53105, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Dresden, Saxony, 01067, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04103, Germany

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Budapest, 1083, Hungary

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Budapest, 1106, Hungary

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Budapest, 1133, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7621, Hungary

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Rome, Lazio, 00133, Italy

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Genoa, Liguria, 16132, Italy

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Milan, Lombardy, 20122, Italy

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Milan, Lombardy, 20132, Italy

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Turin, Piedmont, 10122, Italy

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Cagliari, Sardinia, 09124, Italy

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Sassari, Sardinia, 07100, Italy

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Florence, Tuscany, 50134, Italy

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Padua, Veneto, 35128, Italy

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Kaunas, LT-50009, Lithuania

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Vilnius, LT-08661, Lithuania

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Bydgoszcz, 85-631, Poland

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Gdansk, 80-809, Poland

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Katowice, 40-594, Poland

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Krakow, 31-501, Poland

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Lodz, 91-134, Poland

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Lublin, 20-079, Poland

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Poznan, 61-285, Poland

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Warsaw, 01-013, Poland

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Warsaw, 04-141, Poland

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Coimbra, 3000-548, Portugal

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Leiria, 2410-197, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200-319, Portugal

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Vila Franca de Xira, 2600-178, Portugal

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Bratislava, 826 06, Slovakia

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Bratislava, 85107, Slovakia

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Nitra, 949 01, Slovakia

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Zvolen, 960 01, Slovakia

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Žilina, 01207, Slovakia

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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San Cugat Del Vallès, Barcelona, 08190, Spain

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Albacete, 02006, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Valencia, 46014, Spain

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Bern, Switzerland

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Geneva, 1204, Switzerland

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Camberley, Surrey, GU16 7UJ, United Kingdom

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Guildford, Surrey, GU2 7XX, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

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Sunderland, Tyne and Wear, SR2 9HP, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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London, EC1V 2PD, United Kingdom

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MeSH Terms

Conditions

Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: November 19, 2015
• Primary Completion: August 9, 2017
• Study Completion: August 9, 2017
• Last Updated: October 10, 2018
• Results First Posted: October 10, 2018

Record last verified: 2018-09

Locations

PT (5); FR (2); LI (2); SL (5); CH (2); GB (7); CA (7); HU (5); ES (6); DE (11); PL (9); AU (3); CZ (3); IT (9)