A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
|Central Retinal Vein Occlusion||Device: fluocinolone acetonide (Retisert Implant, Bausch and Lomb)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion|
- 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
- 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.
|Study Start Date:||October 2002|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Experimental: Retisert for Retinal Vein Occlusion
0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
Device: fluocinolone acetonide (Retisert Implant, Bausch and Lomb)
sustained release device consisting of 0.59 mg of fluocinolone acetonide
Other Name: Retisert Implant, Bausch and Lomb, Rochester, NY
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952614
|United States, North Carolina|
|Duke Eye Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Glenn J Jaffe, MD||Duke Eye Center, DUMC|