Clinical Trial: A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Glenn Jaffe

Current Primary Outcome: Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts [ Time Frame: baseline (preoperatively) to 3 years postoperatively ]

Outcome measure based on eyes at time points with 10-letter ETDRS score improvement


Original Primary Outcome: Change from baseline in visual acuity using ETDRS charts [ Time Frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years ]

Current Secondary Outcome: Improvement in Macular Edema on Optical Coherence Tomography and Color Photos [ Time Frame: baseline (preoperatively) to 3 years postoperatively ]

Anatomic Change in reading of the size of the area of retinal thickening on color photographs and OCT. Total Macular Volume (TMV) in mm^3, is the calculated volume from the layers of the retina based off OCT imaging.


Original Secondary Outcome: Amount of macular edema on optical coherence tomography and color photos [ Time Frame: preoperatively, postoperative day 1, week 1, 1 month, 2 months, 6 months, 9 months, 12 months, then every 13 weeks thereafter for a total of 4 years ]

Information By: Duke University

Dates:
Date Received: August 4, 2009
Date Started: October 2002
Date Completion:
Last Updated: August 1, 2014
Last Verified: August 2014