Choroidal Neovascularization Clinical Trial
Official title:
An Open-Label, Pilot Study of Bevacizumab in Subjects With Choroidal Neovascularization Secondary to Diseases Other Than Age-Related Macular Degeneration
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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