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Photodynamic Therapy With Verteporfin for Choroidal Neovascularization Caused by Age-related Macular Degeneration
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.
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