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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Eye Diseases [C11]; Diabetic Retinopathy and diabetic macular edema are leading causes for visual loss and blindness in young adults around the world.; MedDRA version: 18.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853

• Registration Number: EUCTR2015-000959-24-AT
• Lead Sponsor: Abteilung für Augenheilkunde, AKH Linz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-23
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified