Artikel
ILM Peeling versus Triamcinolone in persistent diabetic macular edema (TIME-Study)
Suche in Medline nach
Autoren
Veröffentlicht: | 22. September 2004 |
---|
Gliederung
Text
Aim: Improvement of the visual outcome for patients with persistent diabetic macular edema
Study Design: Three arm parallel group design: two treatment groups, and one control group
Patients: Patients with persistent macular edema (as a consequence of diabetic maculopathy)
Time of the Study: 4 years
Treatment:
• Group 1: control: no treatment
• Group 2: ppV and posterior vitreous detachment + ILM peeling
• Group 3: triamcinolone 4 mg (6 monthly (optional))
Inclusion Criteria:
• Persistent (diffuse or focal) macular edema (more than 6 month) as demonstrated by fluorescein angiography according to ETDRS criteria for CSME associated with diabetes
• BCVA of the treatment eye ≤ 20/50 +3 (≤ 68 ETDRS letters) and ≥ 20/320 (≥ 25 ETDRS letters). Fellow eye ≥ 20/100 (25 ETDRS letters)
• Last focal or grid laser treatment for macular edema more than 3 month prior to treatment
• Type II diabetes
• no changes in the current diabetes treatment for at least 3 month; HbA1c less than 8.5 % for the past 3 month
Exclusion Criteria:
• ischemic maculopathy (foveal avascular zone > 800 µm according to grade 3 ETDRS)
• proliferative retinopathy and associated complications such as bleeding and tractional detachment (ADED)
• additional ocular diseases reducing the visual acuity: retinal artery occlusion, glaucoma in a late stage, mature cataract, choroidal neovascularization, uveitis
• previous antiangiogenic therapy, e.g. interferon
• Type I diabetes
• age under 18 years
• known cortico-steroid responder
• known severe allergies to fluorescein dye
• pregnancy
• complications during surgery requiring endotamponade
• change of current long-term treatment with vasoactive substances such as non-steroidal antiinflammatory drugs or steroids
• participation in another trial
Primary Endpoint:
• long-term effect: difference of 12 month distant visual acuity (ETDRS) to preop vision.
Secondary Endpoint:
• short-term effect: difference of 3 and 6 month distant visual acuity (ETDRS) to preop vision
• reading performance at 3, 6, and 12 month (Radner-Test)
• changes in retinal thickness as measured by OCT determination of vascular leakage by fluorescein angiography
• safety (severe ocular adverse events)
• quality of life questionnaire
Concomitant variables:
• extend of prior macular laser treatment (as determined in FAG)
• requirement of peripheral laser coagulation during follow up
• rate of cataract surgery
• long term glucose control (HbA1c), insulin treatment
• treatment costs
• safety (all adverse events)
Principal Clinical Investigators: Priv.-Doz. Dr. Antonia M. Joussen (Köln); Prof. Dr. Bernd Kirchhof (Köln)
Reading Center: Prof. Dr. Dr. S. Wolf (Leipzig)
Medical Statistics: Prof. Dr. Ralf-Dieter Hilgers (Aachen)
Sponsor: DFG (applied for), Köln Fortune
Status: Ethics approval available, recruitment starting 10/04