Investigation of Eylea for patients with diabetic macular edema in an outpatient Setting.

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2015-000959-24-AT
• Date of registration: 23/07/2015
• Prospective Registration: Yes
• Primary sponsor: Abteilung für Augenheilkunde, AKH Linz
• Public title: Investigation of Eylea for patients with diabetic macular edema in an outpatient Setting.
• Scientific title: Clinical characterization of the treatment of diabetic macular edema with aflibercept in an outpatient setting by evaluation of a regional network of ophthalmologic care givers
• Date of first enrolment: 10/08/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000959-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria

Contacts

• Name: Ophthalmologist
• Affiliation: Abteilung für Augenheilkunde, AKH Linz

• Name: Ophthalmologist
• Affiliation: Abteilung für Augenheilkunde, AKH Linz

Key inclusion & exclusion criteria

Inclusion criteria:
-Men or post-menopausal women
-Presence of clinically significant diabetic macular edema with central involvement, as determined by fundoscopy, optical coherence tomography and /or fluorescence angiography
-Diabetes mellitus Typ I or Typ II
-No treatment of diabetic macular edema of any kind within 3 months prior to inclusion
-No other reason for macular edema or visual impairment except ametropia
-Willingness and able to comply with clinic visits and study-related procedures
-Proved a signed informed consent form
-If both eyes show signs of center involving swelling secondary to DME, the eye with worse visual acuity will be included in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
- Inability to communicate in German or English
- Dementia; inability to follow commands
- Untreated Epilepsy
- Neoplastic disease
- Active intraocular inflammation (grade trace or above) in the study eye.
- Active or suspected ocular or periocular infection in the study eye.
- Allergy to fluorescein
- Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
- Intraocular pressure > 30mm HG at screening



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetic Retinopathy and diabetic macular edema are leading causes for visual loss and blindness in young adults around the world.
MedDRA version: 18.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Trade Name: Eylea
Product Name: Eylea
Pharmaceutical Form: Injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Current Sponsor code: AVE0005
Other descriptive name: AFLIBERCEPT
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Primary end point(s): 1) The visual acuity that can be achieved,
2) the mean number of visits performed at the practitioner’s office and
3) the mean number of injections.

Secondary Objective: Furthermore, this study is designed to describe a possible disease management program for this indication by defining the work flow and the best point of service for each single examination and treatment and the interfaces between practitioner’s offices and a specialized center.

Main Objective: The aim of this study is to describe the outcome of a Treat and Extend regimen with aflibercept (Eylea) in patients with diabetic macular edema (DME). The main idea behind this treatment paradigm is to individualize the intervals of the intravitreal injections that have to be administered on a more or less regular basis. These adapted intervals are an approach to provide each DME patient with an individualized therapy regimen.

Timepoint(s) of evaluation of this end point: The primary endpoint will be after 2 years, an interim analysis is planned after 1 year.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The primary endpoint will be after 2 years, an interim analysis is planned after 1 year.

Secondary end point(s): 1) Retinal Morphology assessed by OCT and FA at year 1, 2 and 3
2) Visual acuity at year 1 and 3
3) Quality of Life at year 1, 2 and 3
4) the mean extension of the treatment intervals during T&E regimen
5) Number of yearly injections
6) Number of unscheduled visits
7) Safety (Number of adverse events)

Secondary ID(s)

DMOE-001-10

Source(s) of Monetary Support

Bayer