Clinical Trial: Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ranibizumab in Idiopathic Macular Telangiectasia, Type 2. A Prospective Interventional Non-randomized Study Comparing the Efficacy and Safety of Intravitreal Ranibizumab i

Brief Summary: The purpose of this study is to investigate if a new drug called ranibizumab is effective to treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type 2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of one year.

Detailed Summary:

Type 2 idiopathic macular telangiectasia (type 2 IMT) is a retinal disease of unknown etiology that commonly presents with a slow decrease in visual acuity, reading difficulties and metamorphopsia in the fifth to seventh decade. Diagnosis is based on fluorescein angiography which typically reveals parafoveal leakage in the late phase and may show telangiectatic capillaries in the early phase. In a subset of patients, a proliferative stage with secondary neovascularizations may develop late in the disease course. In the past, there has been no effective treatment for the disease stages without neovascularization.

Recent studies in a limited number of patients with nonproliferative disease have shown promising results after intravitreal injection of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF). Bevacizumab resulted in a decrease of parafoveal leakage in fluorescein angiography and a decrease in retinal thickness. An increase in visual acuity was reported in a subset of patients.

The RAMA-Trial is initiated in order to investigate the effect of a ranibizumab. The safety and tolerability of this VEGF-antagonist has been extensively studied in large cohorts of patients suffering from age-related macular degeneration.

Patients with type 2 IMT will receive monthly injections over a period of one year. The above mentioned outcome measures will be assessed.


Sponsor: University Hospital, Bonn

Current Primary Outcome: Best corrected visual acuity [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reading ability [ Time Frame: one year ]
  • Scotomas measured by means of microperimetry [ Time Frame: one year ]
  • Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging [ Time Frame: one year ]
  • Changes in parafoveal leakage assessed by fluorescein angiography [ Time Frame: one year ]
  • Quality of life [ Time Frame: one year ]


Original Secondary Outcome:

  • Reading ability [ Time Frame: one year ]
  • Scotomas measured by means of microperimetry [ Time Frame: one year ]
  • Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging [ Time Frame: one year ]
  • Changes in parafoeal leakage assessed by fluorescein angiography [ Time Frame: one year ]
  • Quality of life [ Time Frame: one year ]


Information By: University Hospital, Bonn

Dates:
Date Received: July 18, 2007
Date Started: August 2007
Date Completion:
Last Updated: September 21, 2009
Last Verified: September 2009