F. Gelisken, K. U. Bartz-Schmidt for the Tuebingen Study Group

Purpose:

To report the change of the mean visual acuity of the patients enrolled in the Full Macular Translocation (FMT) vs. Verteporfin Photodynamic Therapy (PDT) study for subfoveal, predominantly classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Design Monocenter, prospective, controlled, randomized, clinical, pilot study. Participants Eligible patients had AMD with subfoveal, predominantly classic CNV on fluorescein angiography and best-corrected VA (BCVA) of 20/40 to 20/200 in the study eye, who did not receive any previous treatment for neovascular
AMD.

Methods:

Randomization was stratified by BCVA, size of the CNV and gender. All patients were scheduled for study examinations at 3, 6, 9, and 12 months after the initial treatment. Main outcome measure (intermediate results) Mean change of BCVA at baseline and at the 6-month examination.

Results:

Of 50 patients enrolled, 25 eyes were assigned to verteporfin PDT and 25 to FMT. Mean BCVA at baseline for the FMT and PDT groups were 20/87 and 20/99 (P=0.2), respectively. At the 6 months examination, mean BCVA was unchanged (mean, 20/101) in the FMT group, whereas it worsened 1.8 ETDRS lines in the verteporfin PDT group (mean, 20/133) (P=0.135). In the FMT arm, 18 phakic eyes had cataract surgery combined with FMT. Retinal detachment occurred in 20% (5/25) of eyes in the FMT group, which necessitated further surgical treatment.

Conclusion:

The results of the presented trial shows, that FMT can improve or preserve BCVA at least for 6 months in eyes with subfoveal predominantly classic CNV secondary to AMD. Verteporfin PDT achieved more likely a stabilisation of the BCVA at 6 months after initial treatment. According the interim results of 6 months follow up, FMT might be considered as an additional alternative therapeutic option in selected cases of subfoveal predominantly classic CNV secondary to neovascular AMD. The one-year results of the FMT vs. PDT Study will be presented at the end of the 2005.