Clinical Trial: Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)

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

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

Brief Summary:

Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.

Hypothesis: A fluocinolone acetonide sustained drug delivery implant will be a safe and effective method to treat patients with macular edema and decreased vision from retinal vein occlusion.


Detailed Summary:

Currently there is limited treatment for macular edema and vision loss due to 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 upto 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 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: 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 ]

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:

  • 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 ]
  • Elevations in Intraocular Pressure (IOP) requiring anti-glaucoma medication or increase in number of medications required or need for drainage surgery to maintain IOP within clinically satisfactory levels. [ 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 ]
  • Quality of life scores using the Visual Functioning (VF)-25 and SF-36 surveys [ 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 ]
  • Ocular adverse events (vitreous hemorrhage, retinal detachment, cataract, endophthalmitis, drug toxicity) [ 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 ]


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 ]
  • Elevations in IOP requiring anti-glaucoma medication or increase in number of medications required or need for drainage surgery to maintain IOP within clinically satisfactory levels. [ 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 ]
  • Quality of life scores using the VF-25 and SF-36 surveys [ 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 ]
  • Ocular adverse events (vitreous hemorrhage, retinal detachment, cataract, endophthalmitis, drug toxicity) [ 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: February 27, 2008
Date Started: October 2002
Date Completion:
Last Updated: December 11, 2012
Last Verified: December 2012