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

Ophthalmology. 2007 Jun;114(6):1179-85. doi: 10.1016/j.ophtha.2007.03.006.

Abstract

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors / adverse effects
  • Angiogenesis Inhibitors / therapeutic use*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Bevacizumab
  • Choroidal Neovascularization / drug therapy*
  • Choroidal Neovascularization / etiology
  • Drug Therapy, Combination
  • Female
  • Fluorescein Angiography
  • Follow-Up Studies
  • Humans
  • Injections
  • Macular Degeneration / complications*
  • Male
  • Middle Aged
  • Photochemotherapy*
  • Photosensitizing Agents / adverse effects
  • Photosensitizing Agents / therapeutic use*
  • Pilot Projects
  • Porphyrins / adverse effects
  • Porphyrins / therapeutic use*
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Verteporfin
  • Visual Acuity
  • Vitreous Body

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Photosensitizing Agents
  • Porphyrins
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Verteporfin
  • Bevacizumab