title: Photodynamic therapy with verteporfin in ocular histoplasmosis: uncontrolled, open-label 2-year study.
abstract: OBJECTIVE
  To evaluate the safety, effect on visual function, and fluorescein angiographic appearance of subfoveal choroidal neovascularization (CNV) through 2 years after photodynamic therapy with verteporfin (Visudyne; Novartis AG, Basel, Switzerland) in patients with ocular histoplasmosis syndrome (OHS).
  
  
  METHODS
  Open-label, 3-center, uncontrolled clinical study.
  
  
  METHODS
  Ocular histoplasmosis syndrome patients with subfoveal CNV (N = 26) with a greatest linear dimension no larger than 5400 microm with classic or occult CNV extending under the geometric center of the fovea, and best-corrected visual acuity letter score of approximately 20/40 to 20/200.
  
  
  METHODS
  The methods were similar to those described in the 1-year results with follow-up examinations every 3 months continuing through the second year. During the second year, additional therapy was recommended if fluorescein angiography showed leakage at a scheduled visit.
  
  
  METHODS
  Visual function measurements included the changes from baseline in visual acuity and contrast sensitivity scores. Lesion size and leakage from classic and occult CNV were assessed at month 12 and month 24. Safety assessments also were made.
  
  
  RESULTS
  A 24-month examination was completed in 22 of the 26 enrolled participants (85%). At the 24-month examination, median improvement from baseline in visual acuity of the 22 patients evaluated was 6 letters; median contrast sensitivity improved by 3.5 letters. At the 24-month examination, 10 patients (45%) gained 7 or more letters of visual acuity from baseline, whereas 4 patients (18%) lost 8 or more letters, including 2 patients (9%) who lost at least 15 letters. There was absence of fluorescein angiographic leakage from classic CNV in 17 of the 20 evaluable lesions (85%), and leakage from occult CNV was absent in all eyes. No serious ocular adverse events were reported, and no serious systemic event was considered to be associated with treatment.
  
  
  CONCLUSIONS
  Median visual acuity improved and fluorescein angiographic leakage decreased after verteporfin therapy in this small, uncontrolled clinical study of patients with subfoveal CNV resulting from OHS. Verteporfin therapy seemed to be relatively safe in these patients. The selected cases feature fluorescein angiographic examples of CNV that are important in determining when to apply verteporfin therapy.
authors.affiliation: Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami School of Medicine, Miami, FL 33136, USA. prosenfeld@med.miami.edu
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Rosenfeld
authors.forename: David A
authors.initials: DA
authors.lastname: Saperstein
authors.forename: Neil M
authors.initials: NM
authors.lastname: Bressler
authors.forename: Troy A
authors.initials: TA
authors.lastname: Reaves
authors.forename: Michel
authors.initials: M
authors.lastname: Sickenberg
authors.forename: Robert H
authors.initials: RH
authors.lastname: Rosa
authors.forename: Paul
authors.initials: P
authors.lastname: Sternberg
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Aaberg
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Aaberg
mesh_terms: D000328:Adult; D000368:Aged; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D015821:Eye Infections, Fungal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005451:Fluorescein Angiography; D006660:Histoplasmosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010778:Photochemotherapy; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011166:Porphyrins / Q000627:therapeutic use*; D012449:Safety; D013577:Syndrome; D016896:Treatment Outcome; D000077362:Verteporfin; D014792:Visual Acuity / Q000502:physiology
chemical_list: D017319:Photosensitizing Agents; D011166:Porphyrins; D000077362:Verteporfin