Funktionelle Ergebnisse der intravitrealen Injektion von Triamcinolonacetonid im Vergleich zur konventionellen Lasertherapie bei diabetischem Makulaödem. - DME-TA

• Conditions: Patients with diffuse macular edema due to diabetic retinopathy and decrease in visual acuity.

• Registration Number: EUCTR2004-005197-23-DE
• Lead Sponsor: Klinik und Poliklinik für Augenheilkunde der Universität Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

?patients with diabetes mellitus II
?signs of diffuse macular edema in both eyes
?indication for (re-)GRID laser-coagulation in both eyes
?best corrected visual acuity of >=0,1 and <0,5
?ability to perform a micro-perimetry-examination
?patient is able and willing to sing the informed consent and to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

?macular illness other than diabetic maculopathy
?previous operation in the macular region of the study eye
?previous chorioretinitis or acute infection of the eye (also conjunctivitis)
?glaucoma or known steroid responder
?immunosuppression
?pregnancy/lactation period
?significant opacities, which preclude a clear view of the macular region in the study eye
?other sever illness, which, in the opinion of the study doctor, precludes participation in the study

Study & Design

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