This Article  • Full text  • PDF  • Correction  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (159)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in this journal  Topic Collections  • Choroidal Neovascularization  • Macular Degeneration  • Retinal/ Chorioretinal Disorders  • Alert me on articles by topic  Social Bookmarking   What's this?

Results of a Single Treatment in a Phase 1 and 2 Study

Joan W. Miller, MD; Ursula Schmidt-Erfurth, MD; Michel Sickenberg, MD; Constantin J. Pournaras, MD; Horst Laqua, MD; Irene Barbazetto, MD; Leonidas Zografos, MD; Bertrand Piguet, MD; Guy Donati, MD; Anne-Marie Lane, MPH; Reginald Birngruber, PhD; Hubert van den Berg, PhD; H. Andrew Strong, PhD; Ulrike Manjuris, PhD; Todd Gray, MSPH; Mario Fsadni, MRCOphth; Neil M. Bressler, MD; Evangelos S. Gragoudas, MD

Arch Ophthalmol. 1999;117:1161-1173.

Objective  To evaluate the safety and short-term visual and fluorescein angiographic effects of a single photodynamic therapy treatment with verteporfin with the use of different dosage regimens in patients with choroidal neovascularization (CNV) from age-related macular degeneration.

Design  Nonrandomized, multicenter, open-label, clinical trial using 5 dosage regimens.

Setting  Four ophthalmic centers in North America and Europe providing retinal care.

Participants  Patients with subfoveal CNV caused by age-related macular degeneration.

Methods  Standardized protocol refraction, visual acuity testing, ophthalmic examination, color photographs, and fluorescein angiograms were used to evaluate the effects of a single treatment of photodynamic therapy with verteporfin. Follow-up was planned through 3 months in 97 patients and for less than 3 months in 31 other patients.

Results  The mean visual acuity change (and range of change) from baseline at the follow-up examination at week 12 after a single treatment with regimens 1 through 5 was -0.2 (-3 to +2), -0.9 (-9 to +5), -1.6 (-9 to +2), +0.4 (-8 to +7), and +0.1 (-8 to +9) lines, respectively. Only the highest light dose (150 J/cm²) in regimens 2 and 3, which produced angiographic nonperfusion of neurosensory retinal vessels, caused marked vision loss. Some cessation of fluorescein leakage from CNV was achieved without loss of vision when the light dose used was less than 150 J/cm². Systemic adverse events were rare. Cessation of fluorescein leakage from CNV was noted in all regimens by 1 week after photodynamic therapy. Fluorescein leakage from at least a portion of the CNV reappeared by 4 to 12 weeks after treatment in almost all cases. Progression of classic CNV beyond the area of CNV identified before treatment was noted in 42 (51%) of the 83 eyes with classic CNV followed up for 3 months after a single treatment. Eyes in which the area of any CNV leakage at 12 weeks was less than at baseline had a significantly better visual acuity outcome (+0.8 line) than eyes in which CNV leakage progressed (-0.8 line).

Conclusions  Photodynamic therapy with verteporfin achieved short-term cessation of fluorescein leakage from CNV without loss of vision or growth of classic CNV in some patients with age-related macular degeneration. Except for nonperfusion of neurosensory retinal vessels at a light dose of 150 J/cm², no other adverse events were of concern. Randomized clinical trials to investigate whether this new modality can preserve vision in patients with CNV secondary to age-related macular degeneration are justified.

From Retina Service, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Mass (Drs Miller and Gragoudas and Ms Lane); the Retina Department, University Eye Hospital, Lübeck, Germany (Drs Schmidt-Erfurth, Laqua, Barbazetto, and Birngruber); Hopital Ophtalmique Jules Gonin, Lausanne, Switzerland (Drs Sickenberg, Zografos, and Piguet); Department of Oto-Neuro-Ophthalmology, Hopital Cantonal Universitaire de Genève, Geneva, Switzerland (Drs Pournaras and Donati); Laboratory of Air Pollution Studies, Department of Environmental Engineering, Ecole Polytechnique Fédérale de Lausanne, Lausanne, Switzerland (Dr van den Berg); QLT PhotoTherapeutics Inc, Vancouver, British Columbia (Drs Strong and Manjuris); CIBA Vision Inc, Duluth, Ga (Mr Gray); CIBA Vision AG, Bülach, Switzerland (Dr Fsadni); and The Wilmer Ophthalmological Institute, The Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, Md (Dr Bressler). The Massachusetts Eye and Ear Infirmary is an owner of a patent covering the use of verteporfin. Should the Massachusetts Eye and Ear Infirmary receive royalties or other financial remuneration related to that patent, Drs Miller and Gragoudas would receive a share of same in accordance with the Massachusetts Eye and Ear Infirmary's institutional Patent Policy and Procedures, which includes royalty-sharing provisions.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLES

Photodynamic Therapy With Verteporfin for Choroidal Neovascularization Caused by Age-related Macular Degeneration: Results of Retreatments in a Phase 1 and 2 Study
Ursula Schmidt-Erfurth, Joan W. Miller, Michel Sickenberg, Horst Laqua, Irene Barbazetto, Evangelos S. Gragoudas, Leonidas Zografos, Bertrand Piguet, Constantin J. Pournaras, Guy Donati, Anne-Marie Lane, Reginald Birngruber, Hubert van den Berg, H. Andrew Strong, Ulrike Manjuris, Todd Gray, Mario Fsadni, and Neil M. Bressler
Arch Ophthalmol. 1999;117(9):1177-1187.
ABSTRACT | FULL TEXT  

Archives of Ophthalmology Reader's Choice: Continuing Medical Education
Arch Ophthalmol. 1999;117(9):1270-1271.
FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Factor VII-Verteporfin for Targeted Photodynamic Therapy in a Rat Model of Choroidal Neovascularization
Lu et al.
IOVS 2009;50:3890-3896.
ABSTRACT | FULL TEXT  

Photoreceptor Protection after Photodynamic Therapy Using Dexamethasone in a Rat Model of Choroidal Neovascularization
She et al.
IOVS 2008;49:5008-5014.
ABSTRACT | FULL TEXT  

Coagulation Gene Predictors of Photodynamic Therapy for Occult Choroidal Neovascularization in Age-Related Macular Degeneration
Parmeggiani et al.
IOVS 2008;49:3100-3106.
ABSTRACT | FULL TEXT  

Photodynamic Therapy Induces Caspase-Dependent Apoptosis in Rat CNV Model
Matsubara et al.
IOVS 2007;48:4741-4747.
ABSTRACT | FULL TEXT  

Reduced Photoreceptor Damage after Photodynamic Therapy through Blockade of Nitric Oxide Synthase in a Model of Choroidal Neovascularization
She et al.
IOVS 2007;48:2268-2277.
ABSTRACT | FULL TEXT  

Intravitreal Bevacizumab for Choroidal Neovascularization Caused by AMD (IBeNA Study): Results of a Phase 1 Dose-Escalation Study.
Costa et al.
IOVS 2006;47:4569-4578.
ABSTRACT | FULL TEXT  

Inhibition of Choroidal Neovascularization by Adenovirus-Mediated Delivery of Short Hairpin RNAs Targeting VEGF as a Potential Therapy for AMD.
Cashman et al.
IOVS 2006;47:3496-3504.
ABSTRACT | FULL TEXT  

Effect of Intravitreal Injection of Ranibizumab in Combination with Verteporfin PDT on Normal Primate Retina and Choroid
Kim et al.
IOVS 2006;47:357-363.
ABSTRACT | FULL TEXT  

Influence of Treatment Parameters on Selectivity of Verteporfin Therapy
Michels et al.
IOVS 2006;47:371-376.
ABSTRACT | FULL TEXT  

Ocular Changes after Photodynamic Therapy
Tzekov et al.
IOVS 2006;47:377-385.
ABSTRACT | FULL TEXT  

Choroidal neovascularisation in pathological myopia: an update in management
Chan et al.
Br J Ophthalmol 2005;89:1522-1528.
ABSTRACT | FULL TEXT  

Verteporfin Therapy of Subfoveal Minimally Classic Choroidal Neovascularization in Age-Related Macular Degeneration: 2-Year Results of a Randomized Clinical Trial
Visudyne in Minimally Classic Choroidal Neovascula
Arch Ophthalmol 2005;123:448-457.
ABSTRACT | FULL TEXT  

Safety and Efficacy of Intravitreal Injection of Ranibizumab in Combination With Verteporfin PDT on Experimental Choroidal Neovascularization in the Monkey
Husain et al.
Arch Ophthalmol 2005;123:509-516.
ABSTRACT | FULL TEXT  

CAI Is a Potent Inhibitor of Neovascularization and Imparts Neuroprotection in a Mouse Model of Ischemic Retinopathy
Franklin et al.
IOVS 2004;45:3756-3766.
ABSTRACT | FULL TEXT  

A prospective study of visual function and quality of life following PDT in patients with wet age related macular degeneration
Armbrecht et al.
Br J Ophthalmol 2004;88:1270-1273.
ABSTRACT | FULL TEXT  

Selective Photodynamic Therapy by Targeted Verteporfin Delivery to Experimental Choroidal Neovascularization Mediated by a Homing Peptide to Vascular Endothelial Growth Factor Receptor-2
Renno et al.
Arch Ophthalmol 2004;122:1002-1011.
ABSTRACT | FULL TEXT  

Clinicopathological findings of choroidal neovascularisation following verteporfin photodynamic therapy
Gelisken et al.
Br J Ophthalmol 2004;88:207-211.
ABSTRACT | FULL TEXT  

Macrophage Depletion Inhibits Experimental Choroidal Neovascularization
Sakurai et al.
IOVS 2003;44:3578-3585.
ABSTRACT | FULL TEXT  

Targeted Disruption of the CD18 or ICAM-1 Gene Inhibits Choroidal Neovascularization
Sakurai et al.
IOVS 2003;44:2743-2749.
ABSTRACT | FULL TEXT  

Apparent Disappearance of Choroidal Neovascularization After Initial Photodynamic Therapy With Verteporfin
Sawa et al.
Arch Ophthalmol 2002;120:1588-1590.
FULL TEXT  

Verteporfin Photodynamic Therapy in the Rat Model of Choroidal Neovascularization: Angiographic and Histologic Characterization
Zacks et al.
IOVS 2002;43:2384-2391.
ABSTRACT | FULL TEXT  

Histopathological Changes Following Photodynamic Therapy in Human Eyes
Schmidt-Erfurth et al.
Arch Ophthalmol 2002;120:835-844.
FULL TEXT  

Age as an Independent Risk Factor for Severity of Experimental Choroidal Neovascularization
Espinosa-Heidmann et al.
IOVS 2002;43:1567-1573.
ABSTRACT | FULL TEXT  

Photodynamic Effects on Choroidal Neovascularization and Physiological Choroid
Schmidt-Erfurth et al.
IOVS 2002;43:830-841.
ABSTRACT | FULL TEXT  

PDT to Monkey CNV with ATX-S10(Na): Inappropriateness of Early Laser Irradiation for Selective Occlusion
Obana et al.
IOVS 2001;42:2639-2645.
ABSTRACT | FULL TEXT  

Suppression of Choroidal Neovascularization by Adeno-associated Virus Vector Expressing Angiostatin
Lai et al.
IOVS 2001;42:2401-2407.
ABSTRACT | FULL TEXT  

The Effect of Axial Length on Laser Spot Size and Laser Irradiance
Stur and Ansari-Shahrezaei
Arch Ophthalmol 2001;119:1323-1328.
ABSTRACT | FULL TEXT  

Age-Related Maculopathy in a Randomized Trial of Low-Dose Aspirin Among US Physicians
Christen et al.
Arch Ophthalmol 2001;119:1143-1149.
ABSTRACT | FULL TEXT  

Electrophysiological changes after 360{degrees} retinotomy and macular translocation for subfoveal choroidal neovascularisation in age related macular degeneration
Luke et al.
Br J Ophthalmol 2001;85:928-932.
ABSTRACT | FULL TEXT  

Treatment of subfoveal choroidal neovascularisation in age related macular degeneration: focus on clinical application of verteporfin photodynamic therapy
SOUBRANE and BRESSLER
Br J Ophthalmol 2001;85:483-495.
FULL TEXT  

A New Drug-Screening Procedure for Photosensitizing Agents Used in Photodynamic Therapy for CNV
Lange et al.
IOVS 2001;42:38-46.
ABSTRACT | FULL TEXT  

Photodynamic Therapy Using Lu-Tex Induces Apoptosis In Vitro, and Its Effect Is Potentiated by Angiostatin in Retinal Capillary Endothelial Cells
Renno et al.
IOVS 2000;41:3963-3971.
ABSTRACT | FULL TEXT  

Antiangiogenic Treatment Enhances Photodynamic Therapy Responsiveness in a Mouse Mammary Carcinoma
Ferrario et al.
Cancer Res. 2000;60:4066-4069.
ABSTRACT | FULL TEXT  

Selective Photodynamic Effects of the New Photosensitizer ATX-S10(Na) on Choroidal Neovascularization in Monkeys
Obana et al.
Arch Ophthalmol 2000;118:650-658.
ABSTRACT | FULL TEXT  

Foveal relocation by redistribution of the neurosensory retina
Wong and Lois
Br J Ophthalmol 2000;84:352-357.
ABSTRACT | FULL TEXT  

Photodynamic Therapy with Verteporfin (Visudyne): Impact on Ophthalmology and Visual Sciences
Bressler and Bressler
IOVS 2000;41:624-628.
FULL TEXT  

A Preliminary Study of Photodynamic Therapy Using Verteporfin for Choroidal Neovascularization in Pathologic Myopia, Ocular Histoplasmosis Syndrome, Angioid Streaks, and Idiopathic Causes
Sickenberg et al.
Arch Ophthalmol 2000;118:327-336.
ABSTRACT | FULL TEXT  

Photodynamic Therapy of Subfoveal Choroidal Neovascularization in Age-related Macular Degeneration With Verteporfin: One-Year Results of 2 Randomized Clinical Trials--TAP Report 1
Treatment of Age-related Macular Degeneration With
Arch Ophthalmol 1999;117:1329-1345.
ABSTRACT | FULL TEXT  

Photodynamic Therapy With Verteporfin Is Effective for Selected Patients With Neovascular Age-related Macular Degeneration
Fine
Arch Ophthalmol 1999;117:1400-1402.
FULL TEXT  

Photodynamic Therapy With Verteporfin for Choroidal Neovascularization Caused by Age-related Macular Degeneration: Results of Retreatments in a Phase 1 and 2 Study
Schmidt-Erfurth et al.
Arch Ophthalmol 1999;117:1177-1187.
ABSTRACT | FULL TEXT