gms | German Medical Science

102. Jahrestagung der DOG

Deutsche Ophthalmologische Gesellschaft e. V.

23. bis 26.09.2004, Berlin

ILM Peeling versus Triamcinolone in persistent diabetic macular edema (TIME-Study)

Meeting Abstract

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Evidenzbasierte Medizin - Anspruch und Wirklichkeit. 102. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft. Berlin, 23.-26.09.2004. Düsseldorf, Köln: German Medical Science; 2004. Doc04dogSA.13.15

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Veröffentlicht: 22. September 2004

© 2004 Joussen.
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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


• 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