Non-arteritic Anterior Ischemic Optic Neuropathy Clinical Trial
Official title:
Intravitreal Bevacizumab for Treatment of the Second Eye With Non-Arteritic Ischemic Optic Neuropathy
Non-Arteritic Ischemic Optic Neuropathy (NAION) is a disease producing swelling of the optic
nerve (the "cable" going from the eye to the brain) resulting in decreased vision. About 15%
of patients will experience NAION in the second eye; many of these patients will be left
legally blind.
Currently, there is no treatment for NAION and for patients in whom the second eye becomes
involved by the disease the outcome can be devastating.
The investigators are conducting a study where the investigators will inject a medication
into the involved eye of patients with NAION. This medication might decrease the swelling of
the optic nerve and improve their vision in that eye.
NAION produces an ischemic insult in the optic nerve head presumably due to the
hypoperfusion of the short ciliary arteries that supply it. This leads to the release of
vascular endothelial growth factor (VEGF) and swelling of the affected area of the nerve.
Vascular endothelial growth factor (VEGF) causes a rapid and reversible increase in vascular
permeability and thus vasogenic edema of the affected area of the optic nerve head.
Subsequently, increased pressure from the swelling of the affected segment causes
compression and infarction of the previously not affected parts of the optic nerve by
creating a sort-of "compartment syndrome".
Bevacizumab is a known anti-Vascular Endothelial Growth Factor (VEGF) agent. It is the
investigators hypothesis that by injecting bevacizumab intra-vitreally the vasogenic edema
will be reduced, preserving viable but threatened optic nerve tissue. One recent case report
described a patient with sequential NAION treated with intra-vitreal bevacizumab who
demonstrated significant improvement in visual acuity and on visual field testing (1). An
editorial in the same issue of the Journal of Neuro-Ophthalmology in which this article
appeared suggested that if the small studies evaluating intra-vitreal injections of
bevacizumab in NAION would support its use in this disease, a large multi-center trial could
be planned (2).
Intra-vitreal injections of bevacizumab have proven to be very safe in treatment of
age-related macular degeneration (3). Because the patients that the investigators are
planning to enroll in this study are faced with the real possibility of blindness with no
therapeutic modality currently available to improve their visual outcome, the investigators
believe that offering them intra-vitreal bevacizumab injection that might halt the
progression of the visual acuity and visual field loss if our hypothesis is correct, would
greatly improve their chances of avoiding blindness.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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