David Maberley1. 1. Department of Ophthalmology, The University of British Columbia, 2550 Willow St., Vancouver, BC, Canada. crtg_vancouver@hotmail.com
Abstract
PURPOSE: To evaluate the efficacy of intravitreal triamcinolone acetonide (ITA) as an adjunct to photodynamic therapy with verteprofin (VPDT) in the treatment of predominantly classic, subfoveal choroidal neovascularization (CNV) owing to age-related macular degeneration (AMD). DESIGN: A multicenter, 2-year, double-blind, randomized, sham-controlled trial conducted at 11 sites in Canada. PARTICIPANTS AND CONTROLS: One hundred individuals over the age of 50 were randomized 1:1 to either to VPDT alone or combined VPDT and ITA. INTERVENTION: Participants all received full-fluence VPDT and were randomly assigned to either (1) a same-day injection of 4 mg ITA or (2) a sham intraocular injection. MAIN OUTCOME MEASURE: The primary end point was the change in numbers of letters read between baseline and 1 year. RESULTS: Combination therapy with VPDT and ITA when compared with VPDT therapy alone resulted in no significant difference in final visual acuity at 1 year. Eyes treated with combination therapy lost an average of 17 letters compared with 20 letters for the VPDT group. Subjects receiving ITA required significantly fewer retreatments over the course of the study (1.28 vs 1.94, respectively; P = 0.003). Although elevated intraocular pressures were noted in a larger proportion of subjects receiving ITA, all of these individuals were managed successfully with topical ocular antihypertensive agents. CONCLUSIONS: There was no visual benefit to the addition of intravitreal triamcinolone to VPDT. Combination therapy, however, can reduce the number of VPDT treatments required by subjects who have predominantly classic CNV owing to AMD. This reduced treatment quantity needs to be weighed against potential side effects. (ClinicalTrials.gov number, NCT00148551).
RCT Entities:
PURPOSE: To evaluate the efficacy of intravitreal triamcinolone acetonide (ITA) as an adjunct to photodynamic therapy with verteprofin (VPDT) in the treatment of predominantly classic, subfoveal choroidal neovascularization (CNV) owing to age-related macular degeneration (AMD). DESIGN: A multicenter, 2-year, double-blind, randomized, sham-controlled trial conducted at 11 sites in Canada. PARTICIPANTS AND CONTROLS: One hundred individuals over the age of 50 were randomized 1:1 to either to VPDT alone or combined VPDT and ITA. INTERVENTION: Participants all received full-fluence VPDT and were randomly assigned to either (1) a same-day injection of 4 mg ITA or (2) a sham intraocular injection. MAIN OUTCOME MEASURE: The primary end point was the change in numbers of letters read between baseline and 1 year. RESULTS: Combination therapy with VPDT and ITA when compared with VPDT therapy alone resulted in no significant difference in final visual acuity at 1 year. Eyes treated with combination therapy lost an average of 17 letters compared with 20 letters for the VPDT group. Subjects receiving ITA required significantly fewer retreatments over the course of the study (1.28 vs 1.94, respectively; P = 0.003). Although elevated intraocular pressures were noted in a larger proportion of subjects receiving ITA, all of these individuals were managed successfully with topical ocular antihypertensive agents. CONCLUSIONS: There was no visual benefit to the addition of intravitreal triamcinolone to VPDT. Combination therapy, however, can reduce the number of VPDT treatments required by subjects who have predominantly classic CNV owing to AMD. This reduced treatment quantity needs to be weighed against potential side effects. (ClinicalTrials.gov number, NCT00148551).