Bevicizumab (Avastin) Infusion for Choroidal Neovascularization (CNV) Not Associated With Age-Related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization; Degenerative Myopia; Pathological Myopia
MeSH terms: Macular Degeneration; Myopia; Choroidal Neovascularization; Myopia, Degenerative; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the drug bevacizumab is safe and effective to use for
      people with choroidal neovascularization (CNV). CNV is an eye condition where abnormal blood
      vessels grow in the part of the eye responsible for central (straight ahead) vision. The drug
      is produced using recombinant DNA technology and has been approved by the FDA for use in
      colon cancer. Although not yet approved for people with CNV, the FDA has given permission to
      use this drug in this study.
    

Detailed description: 
      Bevacizumab is a recombinant humanized monoclonal antibody against VEGF. It has been approved
      by the FDA for the treatment of metastatic colon cancer 18. We hypothesize that VEGF also
      plays a role in the development of CNV in pathologic myopia. Therefore, employing a mode of
      therapy that would decrease the risks posed to eyes with attenuated sclera, we have treated,
      through special approval by the Pharmacy and Therapeutic Committee of the Johns Hopkins
      University School of Medicine, two patients with persistent myopic CNV with intravenous
      bevacizumab 19. Despite multiple treatments with PDT, the CNV remained active and vision
      continued to decline in these two index patients. After four infusions of bevacizumab, the
      CNV became inactive. Six months after the last infusion in each patient, the CNV showed no
      evidence of activity or leakage on fluorescein angiography. Vision also improved in the
      diseased eyes of both patients. The two patients tolerated the infusions well, with no
      adverse events detected. In particular, blood pressure remained stable and no proteinuria was
      noted on serial analyses of 24-hour urine collections. The Bascom Palmer Eye Institute at the
      University of Miami has also recently reported favorable outcomes of bevacizumab administered
      in repeated doses to 14 patients (age > 65 years) with CNV secondary to AMD that has been
      refractory to other therapies.

      We propose a non-randomized, open-label pilot study to evaluate the effect of bevacizumab in
      patients with CNV due to any cause other than AMD. This design will allow us to closely
      monitor safety and tolerability of bevacizumab while we evaluate 3 bioactivity outcomes.
      Based upon dramatic responses in two patients with CNV due to myopic degeneration, we
      hypothesize that treatment with bevacizumab may have major advantages over current standard
      of care.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Choroidal Neovascularization