Full macular translocation (FMT) versus photodynamic therapy (PDT) with verteporfin in the treatment of neovascular age-related macular degeneration: 2-year results of a prospective, controlled, randomised pilot trial (FMT-PDT).
BACKGROUND
To report the outcome of best-corrected visual acuity (BCVA), near visual acuity (NVA), contrast sensitivity (CS) and vision-related quality of life (VRQOL) in patients 2 years after undergoing photodynamic therapy (PDT) or full macular translocation (FMT) for the treatment of neovascular age-related macular degeneration (AMD).


METHODS
Fifty patients with predominantly classic subfoveal choroidal neovascularisation (CNV) secondary to AMD were randomized to PDT or FMT. BCVA was determined according a standardized protocol with ETDRS charts. NVA were calculated after testing with SNAB (Swiss National Association of and for the Blind) visual acuity cards. CS was measured with Pelli-Robson charts. The 39-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25 plus supplement) was performed. Primary end points were the changes of BCVA, NVA, CS and VRQOL at 24-month examination.


RESULTS
A stabilisation of BCVA (+0.3 letters) was found in the FMT group, whereas a decrease of more than 12 letters (-12.6 letters) was found in the PDT group (p = 0.052). Mean NVA improved by 7.0 letters in the FMT group and was superior to the PDT group (-9.6 letters, p = 0.036), while mean CS showed a time-dependent decrease in both treatment groups (FMT: -3.3 letters, PDT: -3.8 letters, p = 0.726). Considering the results of the VRQOL scores, the improvement of the subscales scores for general vision (p = 0.015), mental health (p = 0.028) and near activity (p = 0.020) were significantly higher in the FMT group.


CONCLUSIONS
FMT can stabilise BCVA and improve NVA over a period of 2 years in patients with subfoveal classic CNV secondary to neovascular AMD, whereas a decrease of BCVA and NVA was found in the PDT group. CS did not differ between FMT and PDT. A significant increase of VRQOL scores was only found in the FMT group and not in the PDT group. FMT seems to be a therapeutic approach that can increase visual function resulting in an improvement of patient's VRQOL, but exhibits a higher number of severe complications compared to PDT.
Lüke
Matthias
M
University Eye Hospital, University of Lübeck, Lübeck, Germany. Matthias.Lueke@uk-sh.de
Ziemssen
Focke
F
Völker
Michael
M
Altpeter
Elke
E
Beutel
Julia
J
Besch
Dorothea
D
Bartz-Schmidt
Karl Ulrich
KU
Gelisken
Faik
F
D020256:Choroidal Neovascularization / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D015350:Contrast Sensitivity / Q000502:physiology; D049670:History, 17th Century; D006801:Humans; D008266:Macula Lutea / Q000637:transplantation*; D008268:Macular Degeneration / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D010865:Pilot Projects; D011166:Porphyrins / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000502:physiology
D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin