Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin - 1-year results of a randomized clinical trial - VIP report no. 1

Authors
Arnold, J Kilmartin, D Olson, J Neville, S Robinson, K Laird, A Richmond, C Farrow, A McKay, S Saperstein, DA Aaberg, TM Johnson, JB Waldron, R Loupe, D Gillman, J Myles, B Schachat, AP Bressler, NM Bressler, SB Nesbitt, P Porter, T Hawse, P Hartnett, M Eager, A Belt, J Cain, D Emmert, D George, T Herring, M McDonald, J Mones, J Corcostegui, B Gilbert, M Duran, N Sisquella, M Nolla, A Margalef, A Miller, JW Gragoudas, ES Lane, AM Emmanuel, N Holbrook, A Evans, C Lord, US Walsh, DK Callahan, CD DuBois, JL Lewis, H Kaiser, PK Holody, LJ Lesak, E Lichterman, S Siegel, H Fattori, A Ambrose, G Fecko, T Ross, D Burke, S Singerman, L Zegarra, H Novak, M Bartel, M Tilocco-DuBois, K Iic, M Schura, S Mayes, SJ Tanner, V Rowe, P Smith-Brewer, S Kukula, D Greanoff, G Daley, G DuBois, J Lehnhardt, D Fish, GE Jost, BF Anand, R Callanan, D Arceneaux, S Arnwine, J Ellenich, P King, J Aguado, H Rollins, R Jurklies, B Pauleikhoff, D Hintzmann, A Fischer, M Sowa, C Behne, E Pournaras, CJ Donati, G Kapetanios, AD Cavaliere, K Guney-Wagner, S Gerber, N Sickenberg, M Sickenberg, V Gans, A Hosner, B Sbressa, A Kozma, C Curchod, M Cancelli, SA Harding, S Yang, YC Briggs, M Briggs, S Tompkin, V Jackson, R Pearson, S Natha, S Sharp, J Lim, JI Flaxel, C Padilla, M Levin, L Walonker, F Cisneros, L Nichols, T Schmidt-Erfurth, U Barbazetto, I Laqua, H Kupfer, R Bulow, R Glisovic, B Bredfeldt, T Elsner, H Wintzer, V Bahlmann, D Michels, S Blumenkranz, MS Little, HL Jack, R Espiritu, LM Unyi, L Regan, J Lamborn, L Silvestri, C Rosa, RH Rosenfeld, PJ Lewis, ML Rodriguez, B Torres, A Munoz, N Contreras, T Galvez, M Hess, D Cubillas, T Rams, I Slakter, JS Sorenson, JA Bruschi, PA Burke, K Schnipper, E Maranan, L Scolaro, M Riff, M Agresta, E Johansson, I Dedorsson, I Stenkula, S Hvarfner, C Carlsson, T Liljedahl, AM Fallstrom, S Jacobsson, E Soubrane, G Kuhn, D Oubraham, H Benelhani, A Kunsch, A Delhoste, B Ziverec, G Lasnier, M Lobes, LA Olsen, K Bahr, BJ Worstell, NT Wilcox, LA Wellman, LA Vagstad, G Steinberg, D Campbell, A Dreyer, R Williamson, B Johnson, M Crider, H Margherio, RR Williams, GA Zajechowski, M Stanley, C Kulak, M Streasick, P Szdlowski, L Falk, R Shoichet, S Regan, G Manatrey, P Cumming, K Koenig, F Benchaboune, M Mezmate, K Fontanay, S Meredith, T Binning, J Gualdoni, J Boyd, L Ort, E Barts, B Allen, R Dahl, J Holle, T Harvey, PT Kaus, L Leuschner, D Bolychuk, S Hewitt, I Menchini, U Bandello, F Virgili, G Lanzetta, P Ambesi, M Pirracchio, A Tedeschi, M Potter, MJ Sahota, B Hall, L Stur, M Lukas, J Tittl, M Docker, S Vogl, K Bressler, SB Bressler, NM Pieramici, DJ Manos, KS Cooper, R Denbow, RL Lowery, ER Phillips, DA Thibeault, SK Tian, Y Harnett, M Hawse, P Black, N Escartin, P Hartley, D Haworth, P Hecker, T Hiscock, D Jamali, F Maradan, N North, J Norton, B Stapleton-Hayes, T Taylor, R Huber, G Deslandes, JY Fsadni, M Hess, I de Pommerol, H Bobillier, A Reaves, A Banasik, S Koester, J Gray, T Truett, K Baker, J McAlister, L Birch, R Strong, A Azab, M Buskard, N Manjuris, U Hao, Y Mason, M McCurry, U Barbazetto, I Birngruber, R Bressler, SB Bressler, NM Donati, G Fish, GE Gragoudas, ES Harvey, P Kaiser, PK Koester, JM Lewis, H Lim, JI Ma, C Miller, JW Mones, J Murphy, SA Pieramici, DJ Potter, MJ Pournaras, CJ Schachat, AP Schmidt-Erfurth, U Singerman, L Slakter, JS Soubrane, S Strong, HA van den Berg, H Williams, GA Bressler, NM Manjuris, U Strong, HA Beck, RW Bird, AC Coscas, G Deutman, A Jampol, L Klein, R Maguire, M Deslandes, JY Huber, G Miller, JW Sickenberg, M Rosenfeld, P Stur, M Arceneaux, S Margherio, RP Staflin, P
Citation
J. Arnold et al., Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin - 1-year results of a randomized clinical trial - VIP report no. 1, OPHTHALMOL, 108(5), 2001, pp. 841-852
Citations number
12
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Optalmology,"da verificare
Journal title
OPHTHALMOLOGY
ISSN journal
0161-6420 → ACNP
Volume
108
Issue
5
Year of publication
2001
Pages
841 - 852
Database
ISI
SICI code
0161-6420(200105)108:5<841:PTOSCN>2.0.ZU;2-C
Abstract
Objective: To determine if photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, GA) can improve the chance of stabilizing or imp roving vision (<8 letter loss) safely in patients with subfoveal choroidal neovascularization (CNV) caused by pathologic myopia. Design: Multicenter, double-masked, placebo-controlled, randomized clinical trial at 28 ophthalmology practices in Europe and North America. Participants: One hundred twenty patients with subfoveal CNV caused by path ologic myopia with a greatest linear dimension no more than 5400 <mu>m and best-corrected visual acuity (Snellen equivalent) of approximately 20/100 o r better. Intervention: Patients were randomly assigned (2:1) to verteporfin (6 mg pe r square meter of body surface area; n = 81) or placebo (5% dextrose in wat er, n = 39) administered via intravenous infusion of 30 ml over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm w as delivered at an intensity of 600 mW/cm(2) over 83 seconds to give a ligh t dose of 50 J/cm(2) to a round spot size on the retina with a diameter of 1000 mum larger than the greatest linear dimension of the choroidal neovasc ular lesion. At follow-up examinations every 3 months, retreatment with eit her verteporfin or placebo (as assigned at baseline) was applied to areas o f fluorescein leakage if present. Main Outcome Measures: The primary outcome was the proportion of eyes at th e follow-up examination 12 months after study entry with fewer than eight l etters (approximately 1.5 lines) of visual acuity lost, adhering to an inte nt-to-treat analysis. Results: At baseline, move than 90% of each group had evidence of classic C NV (regardless of whether occult CNV was present) and only 12 (15%) and 5 ( 13%) cases in the verteporfin and placebo groups, respectively, had occult CNV (regardless of whether classic CNV was present). Seventy-nine of the 81 verteporfin-treated patients (98%) compared with 36 of the 39 placebo-trea ted patients (92%) completed the month 12 examination. Visual acuity, contr ast sensitivity, and fluorescein angiographic outcomes were better in the v erteporfin-treated eyes than in the placebo-treated eyes at every follow-up examination through the month 12 examination. At the month 12 examination, 58 (72%) of the verteporfin-treated patients compared with 17 (44%) of the placebo-treated patients lost fewer than eight letters (P < 0.01), includi ng 26 (32%) versus 6 (15%) improving at least five letters (<greater than o r equal to>1 line). Seventy (86%) of the verteporfin-treated patients compa red with 26 (67%) of the placebo-treated patients lost fewer than 15 letter s (P = 0.01), Few ocular or other systemic adverse events were associated w ith verteporfin therapy compared with placebo treatment. Conclusions: Because photodynamic therapy with verteporfin can safely incre ase the chance of stabilizing or improving vision in patients with subfovea l CNV from pathologic myopia compared with a placebo, we recommend ophthalm ologists consider verteporfin therapy for treatment of such patients. Ophth almology 2001; 108:841-852 (C) 2001 by the American Academy of Ophthalmolog y.