gms | German Medical Science

102. Jahrestagung der DOG

Deutsche Ophthalmologische Gesellschaft e. V.

23. bis 26.09.2004, Berlin

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Surgical management of subfoveal choroidal neovascular membranes in age related macular degeneration by macular translocation (MARAN-Studie)

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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.13.10

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dog2004/04dog391.shtml

Published: September 22, 2004

© 2004 Joussen.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Aim: Therapeutical outcome of surgical macular translocation will be evaluated in comparison to the spontaneous course or to established treatments

Study Design: Multicenter, prospective, randomized (1:1) clinical study

Treatments: Macular rotation versus standard treatment (observation, PDT) in patients with exsudative macular degeneration

Patients: Exudative age related macular degeneration (ARMD) with subfoveal choroidal neovascular membranes

Time of the Study: 4 years

Inclusion Criteria:

• Exudative ARMD with subfoveal lesion. CNV can be either classic, occult, or mixed (classic component < 50%) CNV with or without concurrent pigment epithelial detachment and bleeding, as long as the total leason size is not larger than 2 times the size of the membrane itself

• The largest distance from the center of the fovea to the superior edge of the area of the lesion in the fluorescein angiogram must not exceed 2500 µm and to the inferior edge not more than 1500 µm allowing sufficient rotation of the foveal center to clinically uneffected RPE.

• Phacic and pseudophacic eyes

• Visual acuity (ETDRS) of the better eye (study eye) between 0.05 (20/400) and 0.34 (20/60)

Exclusion Criteria:

• Massive subretinal haemorrhage (if the lesion is hidden behind the blood and cannot be assessed).

• Serous PED (total leason size is larger than 2 times the size of the membrane itself)

• Chorioretinal anastomoses

•· Additional ocular diseases reducing the visual acuity: diabetic retinopathy, retinal artery or vein occlusion, glaucoma in a late stage, uveitis.

• Previous treatment of the study eye for ARMD (e.g. laser photocoagulation or PDT, TTT, radiation or antiangiogenic therapy)

Primary Endpoint: change of visual acuity (calculated as the number of lines with at least 4 letters read on the ETDRS charts) at 52 weeks after randomization compared to the visual acuity at baseline

Secondary Endpoint: reading performance stability of fixationquality of life

Principal Investigator: Prof. Dr. Bernd Kirchhof, Cologne

(Koordination: PD Dr. A. Joussen, Cologne)

Medical Statistics: KKS Heidelberg, Dr. M. Seibert-Graefe, Dr. U. Ebert

Sponsor: DFG, Stifterverband

Current status: Ethics comittee approved, recruitment ongoing