Intravitreal bevacizumab for diabetic macular edema associated with severe capillary loss: one-year results of a pilot study

Am J Ophthalmol. 2009 Jun;147(6):1022-30, 1030.e1-5. doi: 10.1016/j.ajo.2009.01.009. Epub 2009 Mar 27.

Abstract

Purpose: To evaluate the effects of intravitreal bevacizumab in patients with diabetic macular edema (DME) associated with severe capillary loss.

Design: Multicenter, open-label, nonrandomized study.

Setting: Two tertiary ophthalmic referral centers in Brazil.

Study population: Ten consecutive patients with DME and "severe" capillary loss.

Observation procedures: Intravitreal injection(s) of bevacizumab (1.5 mg). Standardized ophthalmic evaluation was performed at baseline and at weeks 8, 16, 24, and 54.

Main outcome measures: Changes in best-corrected visual acuity (BCVA) and in optical coherence tomography variables (central macular thickness [CMT] and total macular volume [TMV]).

Results: Significant changes in BCVA and in CMT/TMV were noted throughout the study (P < .001, P = .009, and P < .001, respectively). The mean logarithm of the minimal angle of resolution Early Treatment Diabetic Retinopathy Study BCVA was 0.786 ( approximately 20/125(+1)) at baseline, 0.646 ( approximately 20/80(-2)) at week 8, 0.580 (20/80(+1)) at week 16, 0.574 ( approximately 20/80(+1)) at week 24, and 0.558 ( approximately 20/80(+2)) at week 54. Compared with baseline, a significant change in BCVA was noted at all follow-up visits (P <or= .008). The mean CMT/TMV values were, respectively, 472.6/10.9 at baseline, 371.4/9.9 at week 8, 359.5/9.8 at week 16, 323.9/9.4 at week 24, and 274.6/8.7 at week 54. Compared with baseline, a significant change in both CMT and TMV was noted only at 24 and 54 weeks (P <or= .007). At 54 weeks, fluorescein angiography demonstrated no change in the extent of macular capillary loss and reduced dye leakage as compared with baseline in all patients.

Conclusions: Favorable changes in BCVA and in CMT/TMV observed throughout 1 year suggest that intravitreal bevacizumab may be a viable alternative treatment for the management of patients with DME and severe capillary loss.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Angiogenesis Inhibitors / therapeutic use*
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Bevacizumab
  • Capillaries / pathology
  • Diabetic Retinopathy / diagnosis
  • Diabetic Retinopathy / drug therapy*
  • Diabetic Retinopathy / physiopathology
  • Female
  • Fluorescein Angiography
  • Follow-Up Studies
  • Humans
  • Injections
  • Macular Edema / diagnosis
  • Macular Edema / drug therapy*
  • Macular Edema / physiopathology
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Retinal Vessels / pathology*
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity / physiology
  • Vitreous Body

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Vascular Endothelial Growth Factor A
  • Bevacizumab