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2. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: Two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization-verteporfin in photodynamic therapy report 2
- Author
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Arnold J, Kilmartin D, Olson J, Neville S, Robinson K, Laird A, Richmond C, Farrow A, McKay S, McKechnie R, Evans G, Aaberg TM, Brower J, Waldron R, Loupe D, Gillman J, Myles B, Saperstein DA, Schachat AP, Bressler NM, Bressler SB, Nesbitt P, Porter T, Hawse P, Harnett 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, Moy J, Kenney AG, Milde I, Platz ES, Lewis H, Kaiser PK, Holody LJ, Lesak E, Lichterman S, Siegel H, Fattori A, Ambrose G, Fecko T, Ross D, Burke S, Conway J, Singerman L, Zegarra H, Novak M, Bartel M, Tilocco DuBois K, Ilc M, Schura S, Joyce S, Tanner V, Rowe P, Smith Brewer S, Greanoff G, Daley G, DuBois J, Lehnhardt D, Kukula D, Fish GE, Jost BF, Anand R, Callanan D, Arceneaux S, Arnwine J, Ellenich P, King J, Aguado H, Rollins R, Anderson T, Nork C, Duignan K, Boleman B, 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, Ardoni S, Harding S, Yang YC, Briggs M, Briggs S, Phil EB, Tompkin V, Jackson R, Pearson S, Natha S, Sharp J, Tompkin A, 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, Gordes R, Neppert B, Grote M, Honnicke K, 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, Napoli J, Johansson I, Dedorsson I, Stenkula S, Hvarfner C, Carlsson T, Liljedahl AM, Fallstrom S, Jacobsson E, Hendeberg K, Soubrane G, Kuhn D, Oubraham H, Benelhani A, Kunsch A, Delhoste B, Ziverec G, Lasnier M, Debibie C, Lobes LA, Olsen K, Bahr BJ, Worstell NT, Wilcox LA, Wellman LA, Vagstad G, Steinberg D, Campbell A, Ma C, Dreyer R, Williamson B, Johnson M, Crider H, Anderson H, Brown T, Jelinek K, Graves D, Pope S, Boone R, Beaumont W, Margherio RR, Williams GA, Zajechowski M, Stanley C, Kulak M, Streasick P, Szdlowski L, Falk R, Shoichet S, Regan G, Manatrey P, Cumming K, Fadel R, Mitchel B, Vandell L, Yesestrepsky D, Medina T, Bridges C, Huston G, 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, Voyce J, Menchini U, Virgili G, Lanzetta P, Ambesi M, Pirracchio A, Tedeschi M, Potter MJ, Sahota B, Hall L, Le G, Rai S, Johnson D, Stur M, Lukas J, Tittl M, Docker S, Vogl K, Pieramici DJ, Manos KS, Cooper R, Denbow RL, Lowery ER, Phillips DA, Thibeault SK, Tian Y, Alexander J, Orr PR, 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, Birch R, Koester J, Stickles R, Truett K, McAlister L, Parker F, Strong HA, Azab M, Buskard N, Gray T, Manjuris U, Hao Y, Su XY, Mason M, Hynes L, Barbezetto I, Birngruber R, Flaxel CJ, Harvey P, Koester JM, Meredith TA, Murphy SA, Strong A, Ulrike M, Beck RW, Bird AC, Coscas G, Deutman A, Jampol L, Klein R, Maguire M, Rosenfeld P, Acreneaux S, Margherio RP, Staflin P, Mones JM, Schmidt Erfurth U., BANDELLO , FRANCESCO, Arnold, J, Kilmartin, D, Olson, J, Neville, S, Robinson, K, Laird, A, Richmond, C, Farrow, A, Mckay, S, Mckechnie, R, Evans, G, Aaberg, Tm, Brower, J, Waldron, R, Loupe, D, Gillman, J, Myles, B, Saperstein, Da, Schachat, Ap, Bressler, Nm, Bressler, Sb, Nesbitt, P, Porter, T, Hawse, P, Harnett, 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, E, Lane, Am, Emmanuel, N, Holbrook, A, Evans, C, Lord, U, Walsh, Dk, Callahan, Cd, Dubois, Jl, Moy, J, Kenney, Ag, Milde, I, Platz, E, Lewis, H, Kaiser, Pk, Holody, Lj, Lesak, E, Lichterman, S, Siegel, H, Fattori, A, Ambrose, G, Fecko, T, Ross, D, Burke, S, Conway, J, Singerman, L, Zegarra, H, Novak, M, Bartel, M, Tilocco DuBois, K, Ilc, M, Schura, S, Joyce, S, Tanner, V, Rowe, P, Smith Brewer, S, Greanoff, G, Daley, G, Dubois, J, Lehnhardt, D, Kukula, D, Fish, Ge, Jost, Bf, Anand, R, Callanan, D, Arceneaux, S, Arnwine, J, Ellenich, P, King, J, Aguado, H, Rollins, R, Anderson, T, Nork, C, Duignan, K, Boleman, B, 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, Ardoni, S, Harding, S, Yang, Yc, Briggs, M, Briggs, S, Phil, Eb, Tompkin, V, Jackson, R, Pearson, S, Natha, S, Sharp, J, Tompkin, A, 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, Gordes, R, Neppert, B, Grote, M, Honnicke, K, Blumenkranz, M, 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, J, Sorenson, Ja, Bruschi, Pa, Burke, K, Schnipper, E, Maranan, L, Scolaro, M, Riff, M, Agresta, E, Napoli, J, Johansson, I, Dedorsson, I, Stenkula, S, Hvarfner, C, Carlsson, T, Liljedahl, Am, Fallstrom, S, Jacobsson, E, Hendeberg, K, Soubrane, G, Kuhn, D, Oubraham, H, Benelhani, A, Kunsch, A, Delhoste, B, Ziverec, G, Lasnier, M, Debibie, C, Lobes, La, Olsen, K, Bahr, Bj, Worstell, Nt, Wilcox, La, Wellman, La, Vagstad, G, Steinberg, D, Campbell, A, Ma, C, Dreyer, R, Williamson, B, Johnson, M, Crider, H, Anderson, H, Brown, T, Jelinek, K, Graves, D, Pope, S, Boone, R, Beaumont, W, Margherio, Rr, Williams, Ga, Zajechowski, M, Stanley, C, Kulak, M, Streasick, P, Szdlowski, L, Falk, R, Shoichet, S, Regan, G, Manatrey, P, Cumming, K, Fadel, R, Mitchel, B, Vandell, L, Yesestrepsky, D, Medina, T, Bridges, C, Huston, G, 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, Voyce, J, Menchini, U, Bandello, Francesco, Virgili, G, Lanzetta, P, Ambesi, M, Pirracchio, A, Tedeschi, M, Potter, Mj, Sahota, B, Hall, L, Le, G, Rai, S, Johnson, D, Stur, M, Lukas, J, Tittl, M, Docker, S, Vogl, K, Pieramici, Dj, Manos, K, Cooper, R, Denbow, Rl, Lowery, Er, Phillips, Da, Thibeault, Sk, Tian, Y, Alexander, J, Orr, Pr, 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, Birch, R, Koester, J, Stickles, R, Truett, K, Mcalister, L, Parker, F, Strong, Ha, Azab, M, Buskard, N, Gray, T, Manjuris, U, Hao, Y, Su, Xy, Mason, M, Hynes, L, Barbezetto, I, Birngruber, R, Flaxel, Cj, Harvey, P, Koester, Jm, Meredith, Ta, Murphy, Sa, Strong, A, Ulrike, M, Beck, Rw, Bird, Ac, Coscas, G, Deutman, A, Jampol, L, Klein, R, Maguire, M, Rosenfeld, P, Acreneaux, S, Margherio, Rp, Staflin, P, Mones, Jm, and Schmidt Erfurth, U.
- Abstract
PURPOSE: To determine if photodynamic therapy with verteporfin (Visudyne; Novartis AG, Bulach, Switzerland), termed verteporfin therapy, can safely reduce the risk of vision loss compared with a placebo (with sham treatment) in patients with subfoveal choroidal neovascularization caused by age-related macular degeneration who were identified with a lesion composed of occult with no classic choroidal neovascularization, or with presumed early onset classic choroidal neovascularization with good visual acuity letter score, METHODS: This was a double-masked, placebo controlled (sham treatment), randomized, multicenter clinical trial involving 28 ophthalmology practices in Europe and North America. The study population was patients with age related macular degeneration, with subfoveal choroidal neovascularization lesions measuring no greater than 5400 mum in greatest linear dimension with either 1) occult with no classic choroidal neovascularization, best-corrected visual acuity score of at least 50 (Snellen equivalent approximately 20/100), and evidence of hemorrhage or recent disease progression; or 2) evidence of classic choroidal neovascularization with a best-corrected visual acuity score of at least 70 (better than a Snellen equivalent of approximately 20/40); assigned randomly (2:1) to verteporfin therapy or placebo therapy. Verteporfin (6 mg per square meter of body surface area) or placebo (5% dextrose in water) was administered by means of intravenous infusion of 30 mi over 10 minutes. Fifteen minutes after the start of the infusion, a laser light at 689 nm delivered 50 J/cm(2) by application of an intensity of 600 mW/cm(2) over 83 seconds using a spot size with a diameter 1000 mum larger than the greatest linear dimension of the choroidal neovascularization lesion on the retina. At follow-up examinations every 3 months, retreatment with the same regimen was applied if angiography showed fluorescein leakage. The main outcome measure was at least moderate vision loss, that is, a loss of at least 15 letters (approximately 3 lines), adhering to an intent-to treat analysis with the last observation carried forward to impute for missing data. RESULTS: Two hundred ten (93%) and 193 (86%) of the 225 patients in the verteporfin group compared with 104 (91%) and 99 (87%) of the 114 patients in the placebo group completed the month 12 and 24 examinations, respectively. On average, verteporfin-treated patients received five treatments over the 24 months of follow-up. The primary outcome was similar for the verteporfin-treated and the placebo-treated eyes through the month 12 examination, although a number of secondary visual and angiographic outcomes significantly favored the verteporfin-treated group. Between the month 12 and 24 examinations, the treatment benefit grew so that by the month 24 examination, the vertepor-fin-treated eyes were less likely to have moderate or severe vision loss. Of the 225 verteporfin-treated patients, 121 (54%) compared with 76 (67%) of 114 placebo-treated patients lost at least 15 letters (P =.023). Likewise, 61 of the verteporfin-treated patients (30%) compared with 54 of the placebo-treated patients (47%) lost at least 30 letters (P = .001). Statistically significant results favoring verteporfin therapy at the month 24 examination were consistent between the total population and the subgroup of patients with a baseline lesion composition identified as occult choroidal neovascularization with no classic choroidal neovascularization, This subgroup included 166 of the 225 verteporfin-treated patients (74%) and 92 of the 114 placebo-treated patients (81%). In these patients, 91 of the verteporfin-treated group (55%) compared with 63 of the placebo-treated group (68%) lost at least 15 letters (P =.032), whereas 48 of the verteporfin-treated group (29%) and 43 of the placebo-treated group (47%) lost at least 30 letters (P =.004). Other secondary outcomes, including visual acuity letter score worse than 34 (approximate Snellen equivalent of 20/200 or worse), mean change in visual acuity letter score, development of classic choroidal neovascularization, progression of classic choroidal neovascularization and size of lesion, favored the verteporfin-treated group at both the month 12 and month 24 examination for both the entire study group and the subgroup of cases with occult with no classic choroidal neovascularization at baseline. Subgroup analyses of lesions composed of occult with no classic choroidal neovascularization at baseline suggested that the treatment benefit was greater for patients with either smaller lesions (4 disc areas or less) or lower levels of visual acuity (letter score less than 65, an approximate Snellen equivalent of 20/50(-1) or worse) at baseline. Prospectively planned multivariable analyses confirmed that these two baseline variables affected the magnitude of treatment benefit. Of the 123 verteporfin-treated patients and 64 placebo-heated patients with either visual acuity score Less than 65 or lesion size 4 disc areas or less at baseline, 60 (49%) and 48 (75%) lost at least 15 letters (P < .001), respectively, and 26 (21%) and 31 (48%) lost at least 30 letters (P 2001 by Elsevier Science Inc. All rights reserved.).
- Published
- 2001
3. Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin - 1-year results of a randomized clinical trial - VIP report no. 1
- Author
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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, 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, Pieramici DJ, Manos KS, Cooper R, Denbow RL, Lowery ER, Phillips DA, Thibeault SK, Tian Y, Harnett M, 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, Birngruber R, Harvey P, Koester JM, Ma C, Murphy SA, Soubrane S, Strong HA, van den Berg H, Beck RW, Bird AC, Coscas G, Deutman A, Jampol L, Klein R, Maguire M, Rosenfeld P, Margherio RP, Staflin P., BANDELLO , FRANCESCO, 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, E, Lane, Am, Emmanuel, N, Holbrook, A, Evans, C, Lord, U, 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, M, 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, J, 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, Francesco, 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, Pieramici, Dj, Manos, K, Cooper, R, Denbow, Rl, Lowery, Er, Phillips, Da, Thibeault, Sk, Tian, Y, Harnett, M, 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, Birngruber, R, Harvey, P, Koester, Jm, Ma, C, Murphy, Sa, Soubrane, S, Strong, Ha, van den Berg, H, Beck, Rw, Bird, Ac, Coscas, G, Deutman, A, Jampol, L, Klein, R, Maguire, M, Rosenfeld, P, Margherio, Rp, and Staflin, P.
- Subjects
Photomedicine group - Abstract
Objective: To determine if photodynamic therapy with verteporfin (Visudyne; CIBA Vision Corp, Duluth, GA) can improve the chance of stabilizing or improving vision (m and best-corrected visual acuity (Snellen equivalent) of approximately 20/100 or better. Intervention: Patients were randomly assigned (2:1) to verteporfin (6 mg per square meter of body surface area; n = 81) or placebo (5% dextrose in water, 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 was delivered at an intensity of 600 mW/cm(2) over 83 seconds to give a light 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 neovascular lesion. At follow-up examinations every 3 months, retreatment with either verteporfin or placebo (as assigned at baseline) was applied to areas of fluorescein leakage if present. Main Outcome Measures: The primary outcome was the proportion of eyes at the follow-up examination 12 months after study entry with fewer than eight letters (approximately 1.5 lines) of visual acuity lost, adhering to an intent-to-treat analysis. Results: At baseline, move than 90% of each group had evidence of classic CNV (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-treated patients (92%) completed the month 12 examination. Visual acuity, contrast sensitivity, and fluorescein angiographic outcomes were better in the verteporfin-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), including 26 (32%) versus 6 (15%) improving at least five letters (1 line). Seventy (86%) of the verteporfin-treated patients compared with 26 (67%) of the placebo-treated patients lost fewer than 15 letters (P = 0.01), Few ocular or other systemic adverse events were associated with verteporfin therapy compared with placebo treatment. Conclusions: Because photodynamic therapy with verteporfin can safely increase the chance of stabilizing or improving vision in patients with subfoveal CNV from pathologic myopia compared with a placebo, we recommend ophthalmologists consider verteporfin therapy for treatment of such patients. Ophthalmology 2001; 108:841-852 (C) 2001 by the American Academy of Ophthalmology.
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