A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Central Retinal Vein Occlusion |
Device: fluocinolone acetonide (Retisert Implant, Bausch and Lomb) |
| Study Type: | Interventional |
| 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: 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | October 2002 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are eligible to receive an implant if they met all the following criteria:
- A history of central retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT)
- Macular edema at least one disc area in size that involved the fovea
- Males and non-pregnant females at least 18 years of age
- Intraocular Pressure (IOP) controlled at < 21 mmHg with no more than one topical ocular antihypertensive agent
- Ability and willingness to comply with treatment and follow up process and to understand and sign the informed consent form.
- Initially, patients with central retinal vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide > 12 weeks prior to study entry, with an initial decrease in macular edema and improvement in visual acuity and subsequent decline in visual acuity accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a long-lasting response to a single intravitreal triamcinolone acetonide injection.
Exclusion Criteria:
- Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status.
- Patents with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study.
- Female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
Contacts and Locations| United States, North Carolina | |
| Duke Eye Center | |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: | Glenn J Jaffe, MD | Duke Eye Center, DUMC |
More Information
No publications provided
| Responsible Party: | Glenn Jaffe, Professor, Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00952614 History of Changes |
| Other Study ID Numbers: | Pro00007284 (7300) |
| Study First Received: | August 4, 2009 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
retinal vein occlusion sustained drug delivery implant steroid macular edema |
Additional relevant MeSH terms:
|
Retinal Vein Occlusion Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Fluocinolone Acetonide Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013