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ABSTRACT
Objective: To determine whether verteporfin photodynamic therapy (PDT) can safely reduce the risk of vision loss in patients with subfoveal occult with no classic choroidal neovascularization (CNV) due to age-related macular degeneration.
Research design and methods: Eligible patients were ≥50 years of age with lesion size ≤6 disc areas and best-corrected vision 20/40–20/200. A total of 364 patients with occult with no classic CNV were randomly assigned 2 : 1 to verteporfin PDT (n = 244) or placebo (n = 120). The primary outcome measures were loss of ≥15 and ≥30 letters of visual acuity (VA) from baseline at 12 and 24 months.
Results: A total of 37% and 47% of verteporfin-treated patients versus 45% and 53% of placebo recipients lost ≥15 letters of VA at month 12 and month 24, respectively; 16% and 23% of verteporfin-treated patients versus 17% and 25% of placebo recipients lost ≥30 letters at month 12 and month 24, respectively. These differences were not statistically significant. Four (1.6%) verteporfin-treated patients and one placebo patient (who received verteporfin in error) experienced an acute severe VA decrease; all five patients recovered some degree of vision. No unexpected ocular or systemic adverse events were identified.
Conclusions: Verteporfin PDT in the treatment of occult with no classic CNV was safe and well-tolerated. The differences between the two groups in the primary efficacy variables were not significant. Baseline characteristics and patient selection methods may have contributed to the small treatment effect.
Trial registration: ClinicalTrials.gov identifier: NCT00121407.
Transparency
Declaration of funding
This study was funded by Novartis Pharma AG and QLT Inc.
Declaration of financial/other relationships
A.A., K.B., D.B., P.K.K., J.L. and R.R. have disclosed that they are currently or have been paid as consultants to QLT or Novartis or both. Such payment may include travel expenses at meetings or participation in speakers’ bureaus. H.A.S. and Y.H. have disclosed that they are employees of QLT and hold stock options in QLT. A.W. has disclosed that she is an employee of Novartis.
All peer reviewers receive honoraria from CMRO for their review work. The peer reviewers have disclosed that they have no relevant financial relationships.
Acknowledgment
The authors have disclosed that Y.H. performed the statistical analyses and Christy Costello, ELS (formerly of QLT) provided editing assistance.
The authors have control of primary data and agree to supply to the journal if requested.
The following individuals take authorship responsibility for this paper: Peter K. Kaiser, Andrew Antoszyk, Paul Bernstein, Kevin Blinder, David Boyer, Justin Gottlieb, Larry Halperin, Yong Hao, Leonard Joffe, Jennifer I. Lim, Robert Rosa, H. Andrew Strong, Annemarie Weisberger, Geoff Williams and Keye Wong.