May 2003
Volume 44, Issue 13
ARVO Annual Meeting Abstract  |   May 2003
Verteporfin With Altered (Delayed) Light in Occult CNV (VALIO) – Results of a Phase II Controlled Clinical Trial
Author Affiliations & Notes
  • J.S. Slakter
    Vitreous Ret Mac Consult of NY, New York, NY, United States
  • P.J. Rosenfeld
    Bascom Palmer Eye Institute, Miami, FL, United States
  • VALIO Study Group
    Bascom Palmer Eye Institute, Miami, FL, United States
  • Footnotes
    Commercial Relationships  J.S. Slakter, QLT Inc. F, R; Novartis Ophthalmics F, R; P.J. Rosenfeld, Novartis Ophthalmics F, R; QLT Inc. F, R.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 1101. doi:
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      J.S. Slakter, P.J. Rosenfeld, VALIO Study Group; Verteporfin With Altered (Delayed) Light in Occult CNV (VALIO) – Results of a Phase II Controlled Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2003;44(13):1101.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract: : Purpose: To determine the potential of delaying light application to 30 minutes after initiation of infusion to improve outcomes of photodynamic therapy with verteporfin (Visudyne®, Novartis AG) in AMD patients with occult with no classic CNV. Methods: AMD patients (≥50 years of age) with subfoveal CNV were randomized 1:1 to receive verteporfin therapy with delayed light or verteporfin therapy with standard light application (15 minutes after initiation of infusion). Patients were followed for at least 6 months after initial treatment. Inclusion criteria comprised a lesion composition that was occult with no classic CNV, in which ≥50% of the lesion area was CNV and in which the greatest linear dimension of the lesion was ≤5400 microns on the retina, presumed recent disease progression, and baseline best-corrected visual acuity (approximate Snellen equivalent) 20/50–20/200. Verteporfin therapy was administered at baseline, with the option of an additional treatment at month 3, 6, and 9 if there was evidence of fluorescein leakage from CNV. Best-corrected visual acuity, color fundus photography, and fluorescein and indocyanine green (ICG) angiography were assessed at scheduled follow-up visits through month 6. Potential treatment benefit was assessed based on angiographic outcomes and visual acuity change from baseline. Safety was assessed by evaluating adverse events, visual acuity, color fundus photographs, fluorescein and ICG angiograms. Results: Sixty patients were enrolled at 7 centers in the United States. Most baseline characteristics did not appear different between the two treatment groups (median age 78, 42% men, median total lesion size 8.59 mm² [approximately 4.85 MPS DA]; median area of occult CNV 8.20 mm² [approximately 4.63 MPS DA]) although the baseline median visual acuity score was higher in the standard light application group (58 letters vs. 52 letters [approximate Snellen equivalent 20/64-2 vs 20/100+2] as measured by ETDRS criteria). Angiographic and vision outcomes and safety results through 6 months will be presented. Conclusions: Based on the 6–month results of this phase II randomized, controlled trial, additional trials to evaluate delayed light application may be conducted.

Keywords: age-related macular degeneration • photodynamic therapy • choroid: neovascularization 

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