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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000959-24-AT

Enrollment

Registered

2015-07-23

Start date

2015-08-10

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Concentr

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

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Countries

Austria

Contacts

Public ContactOphthalmologist

Abteilung für Augenheilkunde, AKH Linz

matthias.bolz@akh.linz.at004373278061050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026