Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation
Condition: Telangiectasia
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine whether the drug ranibizumab is an effective treatment for macular
      telangiectasia, a condition in which existing blood vessels near the macula (the back part of
      the eye responsible for sharp central vision) become dilated and twisted, and new abnormal
      blood vessels may form under the retina. Both the existing dilated vessels, as well the new
      subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This
      study will see if ranibizumab can slow or stop the leakage and growth of new vessels forming
      under the retina.

      Patients 18 years of age and older who have macular telangiectasia in both eyes and new blood
      vessel formation under the retina in at least one eye may be eligible for this study. Visual
      acuity must be 20/40 or worse.

      Participants receive at least four injections of ranibizumab into the eye over a 12-week
      period. After the fourth injection, additional injections may be given every 4 weeks for up
      to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab
      treatment, patients undergo the following procedures:

        -  Medical history and physical examination.

        -  Eye examination, including dilation of the pupils and measurement of the fluid pressure
           in the eye.

        -  Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the
           blood vessels in the eyes. Photographs of the retina are taken with a special camera
           that flashes a blue light into the eye. The photos show whether any dye has leaked from
           the vessels into the retina.

        -  Indocyanine green angiography: This procedure identifies feeder vessels that may be
           supplying the abnormal blood vessels. The test is similar to fluorescein angiography,
           but uses a green dye and flashes an invisible light.

        -  Autofluorescence imaging: This test examines how well the retina functions. The back of
           the eye is photographed with a bright light.

        -  Optical coherence tomography: This test measures retinal thickness. A light shined into
           the eye produces cross-sectional pictures of the retina. The measurements are repeated
           during the study to determine if retinal thickening is getting better or worse, or
           staying the same.

        -  Stereoscopic color fundus photography: The pupils are dilated and special photographs of
           the inside of the eye are taken to evaluate the retina and measure changes that occur
           over time. The camera flashes a bright light into the eye for each picture.

        -  Follow-up visits: The doctor evaluates the effects of the study treatment before and
           after each injection. Patients are contacted by phone 3 days after each injection to
           check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after
           the last treatment.
    

Detailed description: 
      Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting
      the retinal capillaries in which irregular capillary dilation and incompetence occur in the
      macula. This is the former group 2 in the Gass classification of idiopathic juxtafoveal
      telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These
      patients typically are diagnosed in their fifth or sixth decade of life. Both sexes may be
      affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle
      venules characterize this disorder. As the disease progresses, intraretinal pigment plaques
      and eventually subretinal/choroidal neovascularization develop. Currently, these patients
      will be classified as macular telangiectasia. The pathogenesis of the disease is unknown.
      Because of the leakage of the retinal vessels and also the finding of neovascularization, it
      is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.

      The purpose of this study is to evaluate the possible role of ranibizumab for the treatment
      of five participants with macular telangiectasia with hyperfluorescence on fluorescein
      angiography, with vision decreased to 20/40 or worse, with neovascularization. The primary
      outcome will be a visual acuity change, either increase or decrease of 15 letters or more at
      one year. The secondary outcomes measured at one year will include visual acuity changes of
      10 letters or more, the change in retinal thickening documented by OCT, the extent and degree
      of fluorescein leakage, the change in area of hypofluorescence, and the change in central
      retinal sensitivity. This is a pilot study designed to evaluate the feasibility and potential
      efficacy of treating patients with macular telangiectasia in a larger, phase III study within
      the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation. Currently,
      the research group is enrolling 200 patients affected with this condition for a natural
      history study in 22 international clinical centers.
    

Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperfluorescence on Fluorescein; Idiopathic Juxtafoveal Telangiectasia; Retinal Edema/Thinning; Vascular Endothelial Growth Factor; Macular Telangiectasia