Please use this identifier to cite or link to this item: http://repositorio.unifesp.br/handle/11600/42653
Title: Interferon alfa-2a is ineffective for patients with choroidal neovascularization secondary to age-related macular degeneration - Results of a prospective randomized placebo-controlled clinical trial
Authors: Guyer, D. R.
Adamis, P. A.
Bird, A.
Brancato, R.
Coscas, G.
Gragoudas, E.
Yannuzzi, L. A.
OShaughnessy, D.
Slakter, J. S.
Miller, J. W.
Soubrane, G.
Buyse, M.
Melis, C.
DeRosa, J. T.
Baes, P.
Bressler, N.
Bressler, S.
Alexander, J.
Cooper, R.
Javornik, N.
Orlock, D.
Hanutsaha, P.
Chang, A.
Mott, D.
Betts, F.
Smith, H.
Ward, C.
Lane, A. M.
Bang, D.
Finn, S.
Harmon, D.
Dow, E.
Brucker, A.
DuPont, J.
Sorenson, J.
Napoli, J.
Daly, J.
Burke, K.
Bollenbacher, E.
Folk, J.
Reddy, C.
Boldt, C.
Kimura, A. E.
Griffin, M.
Gitter, K.
Newell, K.
Johnson, M.
Blodi, B.
Elner, S.
Vine, A.
Jessup, L.
Jost, B.
Callanan, D.
Fish, G. E.
Anderson, T.
Fogelman, K.
Klein, M.
Nolte, S.
Lewis, M. L.
Rodriguez, B.
Mieler, W.
Pulido, J.
Newman, J.
Sjaarda, R.
Glaser, B.
Murphy, R.
Thompson, J.
Donahue, D.
Nanda, S.
Kingsley, R.
Shofner, J.
Orth, D.
Larsen, T.
Schachat, A.
Petty, B.
Nesbitt, P.
Schatz, H.
McDonald, H. R.
Johnson, R.
DiAngelo, M.
Singerman, L.
Zegarra, H.
Lichterman, S.
Sternberg, P.
Johnson, J.
Tiedeman, J. S.
Comway, B. P.
Henofer, M. J.
Williams, G.
Cumming, K.
Burgess, D.
Williams, D.
Venverloh, S.
Ambler, J.
Moss, S.
Mitchell, P.
Wang, J. J.
Stur, M.
Tittl, M.
Vogelmuller, M.
Belfort, Rubens Junior [UNIFESP]
Bonomo, Pedro Paulo [UNIFESP]
Farah, Michel Eid [UNIFESP]
Cunha, S. L.
Takahashi, W.
Souza, E. C.
Harvey, P. T.
Fralick, R. A.
Kraus, L.
Sjoelie, A. K.
Moeller, F.
Engler, C.
Sander, B.
Immonen, I
Jaakkola, A.
Hyyppa, T.
Koenig, F.
Beuchaboune, M.
Hansen, L.
Janknecht, P.
Guhlmann, M.
Kampik, A.
Scheider, A.
Ulbig, M.
Kiraly, A.
Richard, G.
Weckerle, P.
Holz, F. G.
Volcker, H. E.
Yassur, Y.
Loewenstein, A.
Rosenblatt, I
Avanza, P.
Cardia, L.
Boscia, F.
Ferrari, T. M.
Durante, G.
Papoff, G.
deJong, TVM
vanSanten, C. A.
CunhaVaz, J.
Silva, R.
Bauer, B.
Sjoeberg, U.
Agardh, E.
Matensson, E.
Pournaras, C.
Stepanian, E.
Zografos, L.
Piquet, B.
Owens, S.
Chisholm, I
Hill, J.
Parish, K.
COORDINATING CTR
INT INST DRUG DEV
WILMER READING CTR
ICG READING CTR
HOFFMANN LA ROCHE INC
UNIV PENN
VITREOUS RETINA MACULA CONSULTANTS NY
UNIV IOWA HOSP & CLIN
UNIV MICHIGAN
TEXAS RETINA ASSOCIATES
CASEY EYE INST
BASCOM PALMER EYE INST
MED COLL WISCONSIN
RETINA INST MARYLAND
DEAN A MCGEE EYE INST
IRWIN RETINA CTR
JOHNS HOPKINS UNIV HOSP
RETINA ASSOCIATES
EMORY UNIV
UNIV VIRGINIA
ASSOCIATED RETINAL CONSULTANTS
BARNES HOSP
PRINCESS ALEXANDRA HOSP
WESTMEAD HOSP
AUGENKLIN
Universidade Federal de São Paulo (UNIFESP)
Universidade de São Paulo (USP)
BONOMO OFTALMOL
UNIV TORONTO
AARHUS KOMMUNE HOSP
KAS HERLEV
HELSINKI EYE HOSP
HOP BELLEVUE
UNIV MUNICH
UNIV FREIBURG
UNIV HAMBURG
UNIV HEIDELBERG
BEILINSON MED CTR
UNIV MILAN
INST CLIN OCULIST
NETHERLANDS OPHTHALM RES INST
ACAD ZIEKENHUIS
UNIV COIMBRA HOSP
UNIV LUND HOSP
HOP CANTONAL
HOP OPHTALM JULES GONIN
SOUTHAMPTON EYE INST
MOORFIELDS EYE HOSP
UNIV PARIS 12
HARVARD UNIV
Issue Date: 1-Jul-1997
Publisher: Amer Medical Assoc
Citation: Archives Of Ophthalmology. Chicago: Amer Medical Assoc, v. 115, n. 7, p. 865-872, 1997.
Abstract: Background: Interferon alfa-2a has been shown to be effective as an antiangiogenic agent for several systemic human angiogenic disorders and has shown antiangiogenic activity in the laboratory.Objective: To evaluate the safety and efficacy of interferon alfa-2a for the treatment of choroidal neovascularization secondary to age-related macular degeneration.Methods: A randomized, placebo-controlled, parallel, multicenter double-blind trial was performed at 45 ophthalmic centers worldwide. Four hundred eighty-one patients were randomly assigned to 4 treatment groups: placebo or or interferon alfa-2a (Roferon-A), 1.5, 3.0, or 6.0 million international units (MIU). Visual acuity testing, clinical examination, fluorescein angiography, and indocyanine green angiography were evaluated, with the primary end point being a comparison of the number of patients who experienced a loss of 3 lines or more of vision at 1 year.Results: At 52 weeks, 40 (38%; 95% confidence interval, 29%-48%) of 105 placebo-treated patients had lost at least 3 lines of vision (with 12% unavailable for follow-up), compared with 142 (50%; 95% confidence interval, 44%-55%) of 286 in che 3 active treatment groups combined. The difference in proportions was not statistically significant. However, a pairwise comparison of these proportions for the placebo group vs the group that received interferon alfa-2a, 6 MIU (with 26% unavailable for follow-up), showed a statistically significant difference in favor of the placebo group (P=.02) and a nearly significant difference for the placebo vs the 1.5-MIU group (P=.05) (with 16% unavailable for follow-up), again favoring the placebo group. The 3-MIU group (with 22% unavailable for follow-up) did not show a statistically significant difference in pairwise comparison (P=.48), suggesting that a dose-response relationship was not evident.Conclusion: Interferon alfa-2a provides no benefit as a treatment for choroidal neovascularization secondary to age-related macular degeneration and may be associated with a poorer visual outcome when given at a dose of 6 MIU. However, the absence of a clear dose-response relationship raises the possibility that the observed differences result from chance.
URI: http://repositorio.unifesp.br/11600/42653
ISSN: 0003-9950
Other Identifiers: http://dx.doi.org/10.1001/archopht.1997.01100160035005
Appears in Collections:Artigo

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