Verteporfin therapy and intravitreal bevacizumab combined and alone in choroidal neovascularization due to age-related macular degeneration.

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.