Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Device: fluocinolone acetonide (Retisert Implant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are eligible to receive an implant if they met all the following criteria: A history of 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vein Occlusion Eye<br>Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device | Device: fluocinolone acetonide (Retisert Implant)<br>* sustained release device consisting of 0.59 mg of fluocinolone acetonide<br>* Other names: Retisert Implant, Bausch and Lomb, Rochester, NY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of macular edema on optical coherence tomography and color photos |  | 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. |  | 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 |  | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal vein occlusion, sustained drug delivery implant, steroid, macular edema