Monthly ranibizumab for nonproliferative macular telangiectasia type 2: a 12-month prospective study

Am J Ophthalmol. 2011 May;151(5):876-886.e1. doi: 10.1016/j.ajo.2010.11.019. Epub 2011 Feb 19.

Abstract

Purpose: To investigate the efficacy and safety of intravitreal ranibizumab for the treatment of nonproliferative macular telangiectasia (MacTel) type 2.

Design: Prospective, open-label, uncontrolled, nonrandomized interventional clinical trial.

Methods: One eye (disease stage 2 or 3) of each patient (n = 10) with nonproliferative MacTel type 2 was injected with 0.5 mg ranibizumab at monthly intervals for one year. Visual acuity, angiographic findings, and retinal thickness were assessed at each visit. The primary endpoint was the change in best-corrected distance visual acuity after one year compared to baseline.

Results: Mean visual acuity showed a transient increase in the study eye. However, after 12 months of treatment there was no significant change of visual acuity compared to baseline or compared to the fellow eye. Fluorescein angiography revealed a decrease of telangiectatic-appearing capillaries and of late-phase leakage, which was accompanied by a topographically related significant reduction in macular thickness. Three to 5 months after the last treatment, angiographic appearance and retinal thickness were similar to baseline. In one patient, the last intravitreal injection was not performed because of safety concerns after a transitory ischemic attack. Otherwise, no serious adverse events were observed.

Conclusions: The angiographic and tomographic effects after intravitreal inhibition of vascular endothelial growth factor (VEGF) using ranibizumab implicate a pathophysiological role of the VEGF pathway in nonproliferative MacTel type 2. As the morphologic response was not associated with a clear functional benefit, and because of the transient nature of the treatment effect, monthly intravitreal ranibizumab is not recommended for the nonproliferative disease stage of MacTel type 2.

Trial registration: ClinicalTrials.gov NCT00504400.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angiogenesis Inhibitors / administration & dosage*
  • Angiogenesis Inhibitors / adverse effects
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal, Humanized
  • Female
  • Fluorescein Angiography
  • Humans
  • Intravitreal Injections
  • Male
  • Middle Aged
  • Prospective Studies
  • Ranibizumab
  • Retinal Telangiectasis / classification
  • Retinal Telangiectasis / drug therapy*
  • Retinal Telangiectasis / physiopathology
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity / physiology

Substances

  • Angiogenesis Inhibitors
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Ranibizumab

Associated data

  • ClinicalTrials.gov/NCT00504400