title: 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.
abstract: 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.
  
  
  METHODS
  Nonrandomized, multicenter, open-label, clinical trial using 5 dosage regimens.
  
  
  METHODS
  Four ophthalmic centers in North America and Europe providing retinal care.
  
  
  METHODS
  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.
authors.affiliation: Retina Service, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, USA. jwmiller@meei.harvard.edu
authors.forename: J W
authors.initials: JW
authors.lastname: Miller
authors.forename: U
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.forename: M
authors.initials: M
authors.lastname: Sickenberg
authors.forename: C J
authors.initials: CJ
authors.lastname: Pournaras
authors.forename: H
authors.initials: H
authors.lastname: Laqua
authors.forename: I
authors.initials: I
authors.lastname: Barbazetto
authors.forename: L
authors.initials: L
authors.lastname: Zografos
authors.forename: B
authors.initials: B
authors.lastname: Piguet
authors.forename: G
authors.initials: G
authors.lastname: Donati
authors.forename: A M
authors.initials: AM
authors.lastname: Lane
authors.forename: R
authors.initials: R
authors.lastname: Birngruber
authors.forename: H
authors.initials: H
authors.lastname: van den Berg
authors.forename: A
authors.initials: A
authors.lastname: Strong
authors.forename: U
authors.initials: U
authors.lastname: Manjuris
authors.forename: T
authors.initials: T
authors.lastname: Gray
authors.forename: M
authors.initials: M
authors.lastname: Fsadni
authors.forename: N M
authors.initials: NM
authors.lastname: Bressler
authors.forename: E S
authors.initials: ES
authors.lastname: Gragoudas
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002199:Capillary Permeability / Q000187:drug effects; D002829:Choroid / Q000098:blood supply; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism / Q000473:pathology; D005260:Female; D019793:Fluorescein / Q000378:metabolism; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D006801:Humans; D008268:Macular Degeneration / Q000150:complications*; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D012029:Refraction, Ocular; D012449:Safety; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin; D019793:Fluorescein