OBJECTIVE: To evaluate the efficacy and safety of photodynamic therapy (PDT) with verteporfin combined with intravitreal bevacizumab in choroidal neovascularization (CNV) owing to age-related macular degeneration (AMD) in comparison with individual monotherapies used as controls. DESIGN: Randomized controlled pilot clinical trial. PARTICIPANTS: Males or females, aged > or =50 years, with minimally classic or occult CNV owing to AMD in at least 1 eye that had never been treated previously. METHODS:One hundred sixty-five eyes in 165 subjects (53 males, 112 females) aged between 60 and 87 years (mean [standard deviation]: 75.7 [6.0] years) were randomly assigned to receive either a single PDT session with verteporfin (PDT group; n = 55), or a single administration of intravitreal bevacizumab (1.25 mg; BEV group; n = 55), or their combination (COMB group; n = 55). In the COMB group, bevacizumab was administered within 1 hour of PDT. Subjects were followed up at 1 and 3 months after treatment. Ophthalmic evaluations including optical coherence tomography, fluorescein angiography, and visual acuity (VA) and central foveal thickness (CFT) measurements were performed at each visit. MAIN OUTCOME MEASURES: Changes from baseline in best-corrected VA and CFT measured at 1- and 3-month follow-up visits. RESULTS:One hundred fifty-six subjects (54 BEV, 50 PDT, and 52 COMB) completed the study. At the 3-month follow-up, significant improvements in best-corrected VA were observed in the BEV and COMB groups (0.079 and 0.223 logarithm of the minimum angle of resolution [logMAR], respectively; P<0.0001 for both). In the PDT group, a slight worsening was noted. Significant reductions of CFT were observed in the 3 groups (-34.0 microm [BEV], -59.6 microm [COMB], and -50.5 microm [PDT]; P<0.0001 for all). At the 1-month follow-up, 46 subjects (16 BEV, 29 COMB, and 1 PDT) had an improvement >0.2 logMAR in best-corrected VA; at 3-month follow-up, this improvement persisted in 23 subjects (1 BEV, 22 COMB, and 0 PDT). CONCLUSIONS: Significant improvements in best-corrected VA after 1 month and their maintenance over a 3-month period were observed after verteporfin PDT combined with intravitreal bevacizumab. These results should be confirmed in larger and long-term prospective randomized trials.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of photodynamic therapy (PDT) with verteporfin combined with intravitreal bevacizumab in choroidal neovascularization (CNV) owing to age-related macular degeneration (AMD) in comparison with individual monotherapies used as controls. DESIGN: Randomized controlled pilot clinical trial. PARTICIPANTS: Males or females, aged > or =50 years, with minimally classic or occult CNV owing to AMD in at least 1 eye that had never been treated previously. METHODS: One hundred sixty-five eyes in 165 subjects (53 males, 112 females) aged between 60 and 87 years (mean [standard deviation]: 75.7 [6.0] years) were randomly assigned to receive either a single PDT session with verteporfin (PDT group; n = 55), or a single administration of intravitreal bevacizumab (1.25 mg; BEV group; n = 55), or their combination (COMB group; n = 55). In the COMB group, bevacizumab was administered within 1 hour of PDT. Subjects were followed up at 1 and 3 months after treatment. Ophthalmic evaluations including optical coherence tomography, fluorescein angiography, and visual acuity (VA) and central foveal thickness (CFT) measurements were performed at each visit. MAIN OUTCOME MEASURES: Changes from baseline in best-corrected VA and CFT measured at 1- and 3-month follow-up visits. RESULTS: One hundred fifty-six subjects (54 BEV, 50 PDT, and 52 COMB) completed the study. At the 3-month follow-up, significant improvements in best-corrected VA were observed in the BEV and COMB groups (0.079 and 0.223 logarithm of the minimum angle of resolution [logMAR], respectively; P<0.0001 for both). In the PDT group, a slight worsening was noted. Significant reductions of CFT were observed in the 3 groups (-34.0 microm [BEV], -59.6 microm [COMB], and -50.5 microm [PDT]; P<0.0001 for all). At the 1-month follow-up, 46 subjects (16 BEV, 29 COMB, and 1 PDT) had an improvement >0.2 logMAR in best-corrected VA; at 3-month follow-up, this improvement persisted in 23 subjects (1 BEV, 22 COMB, and 0 PDT). CONCLUSIONS: Significant improvements in best-corrected VA after 1 month and their maintenance over a 3-month period were observed after verteporfin PDT combined with intravitreal bevacizumab. These results should be confirmed in larger and long-term prospective randomized trials.
Authors: Mark J Ratain; Rachel W Humphrey; Gary B Gordon; Gwen Fyfe; Peter C Adamson; Thomas R Fleming; Walter M Stadler; Donald A Berry; Carl C Peck Journal: Eur J Cancer Date: 2007-11-05 Impact factor: 9.162
Authors: Alexandros A Rouvas; Thanos D Papakostas; Ioannis D Ladas; Ioannis Vergados Journal: Graefes Arch Clin Exp Ophthalmol Date: 2007-10-24 Impact factor: 3.117