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Objective:

Efficacy of Primary ICG-directed PDT Triple Therapy with verteporfin (Visudyne), ranibizumab (Lucentis), and triamcinolone acetonide (Triescence) versus €˜Standard of Care, i.e. anti-VEGF monotherapy, for the treatment of Exudative ARMD.

Design:

Retrospective, non-randomized, exploratory study.

Methods:

2 year study of 115 patients (120 eyes) with treatment-naive Exudative ARMD, VA 0.1 to 1.00 LOGMAR units, who were placed into three treatment arms in a non-randomized manner: 1. Standard of Care protocol (66 patients) – Monthly, fixed-interval ranibizumab (Lucentis) monotherapy for 12 months. Subsequently divided into two groups for months 13-24 in a non-randomized fashion. a. Monthly, fixed-interval ranibizumab (Lucentis) monotherapy continuation of monthly treatments – 34 patients b. Treat and Extend (T&E), non-fixed interval ranibizumab (Lucentis) monotherapy after year of monthly injections, second year consisted of q 6 weeks x 2, q8 weeks x 2, and q10 weeks x 2, 32 patients 2. Primary ICG-directed PDT Triple Therapy (PTT) protocol 54 patients.

Main Outcome Measures:

  • Primary: Visual acuity gain at year 2, duration of treatment.
  • Secondary: OCT thickness reduction at year 2, sub-analysis of visual gain at year 2 (lines gained, lines lost), cost per letter gained.

Results:

  • 1. Primary ICG-directed PDT Triple Therapy (PTT) is a safe and effective treatment for patients with Exudative ARMD.
  • 2. Primary outcome The visual acuity improvement at 2 years associated with PTT is statistically inferior compared to monthly ranibizumab (Lucentis) monotherapy but not compared to a Treat and Extend protocol. However, fluctuating vision is common with protocols. Best VA results reveal that the best treatment success occurred outside of the fixed Yr 1 and Yr 2 readings. When the results are compared to the Best VA data, PTT is not statistically inferior to the monthly ranibizumab (Lucentis) monotherapy.
  • 3. Primary outcome – The clearest outcome that proves the advantage of PTT is the time between treatments (37 weeks). The reduction of treatment burden is profound.
  • 4. Secondary outcomes: a. OCT data reveals no difference in the ability of each treatment protocol to reduce exudation associated with neovascularization when measured at 1 and 2 years. b. The cost per letter gained was $3,744 with Lucentis monotherapy, $1,635 with PTT and $7,020 for the ‘Treat and Extend protocol. If the best VA is used for PTT, the cost is $779.