Central Retinal Vein Occlusion Clinical Trial
Official title:
A Pilot Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
The purpose of this study is to determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of central retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.
Currently there is limited treatment for macular edema and vision loss due to central
retinal vein occlusion. Case reports have shown some benefit of intravitreal steroid
injections in improving vision and reducing macular edema in eyes with retinal vein
occlusions.
Recently, a sustained drug release steroid implant has been investigated and FDA approved to
treat macular edema in patients with non-infectious uveitis, eye inflammation. This implant
is placed through an incision in the eye wall and is designed to deliver a steroid,
fluocinolone acetonide, for up to three years. In animal studies there was no detectable
steroid seen in the blood stream.
This pilot trial will recruit individuals who have had a central retinal vein occlusion in
at least one eye. If the macular edema and vision improves with an initial intravitreal
injection, the eye will be considered to receive the sustained drug release device. The
dosage of fluocinolone acetonide used is 0.59 mg.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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