Clinical trial NCT02581995: Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Keywords: Diabetic macular edema
Intravitreal injection
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Week 52 in NEI VFQ-25 Total Score
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale
timeFrame: Baseline, Week 52
measure: Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale
timeFrame: Baseline, Week 52
measure: Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score])
timeFrame: Baseline, Week 52
measure: Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, Week 52
measure: Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP)
timeFrame: Baseline, Week 52
Other outcomes:
measure: Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks
timeFrame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52
measure: Change From Baseline in Systolic Blood Pressure at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Diastolic Blood Pressure at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Heart Rate at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Body Temperature at Week 52
timeFrame: Baseline, Week 52
Locations:
city: Graz
country: Austria
state: Steiermark
city: Wien
country: Austria
city: Wien
country: Austria
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Hradec Kralove
country: Czechia
city: Praha 10
country: Czechia
city: Usti nad Labem
country: Czechia
city: Creteil Cedex
country: France
city: Marseille
country: France
city: Darmstadt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Göttingen
country: Germany
state: Niedersachsen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Firenze
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Coimbra
country: Portugal
city: Leiria
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Vila Franca de Xira
country: Portugal
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Zilina
country: Slovakia
city: Zvolen
country: Slovakia
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: San Cugat Del Vallès
country: Spain
state: Barcelona
city: Albacete
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Southampton
country: United Kingdom
state: Hampshire
city: Camberley
country: United Kingdom
state: Surrey
city: Guildford
country: United Kingdom
state: Surrey
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Sunderland
country: United Kingdom
state: Tyne And Wear
city: Leeds
country: United Kingdom
state: West Yorkshire
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: