Central Retinal Vein Occlusion Clinical Trial
Official title:
A Pilot Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Verified date | August 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke Eye Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Glenn Jaffe | Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts | Outcome measure based on eyes at time points with 10-letter ETDRS score improvement | baseline (preoperatively) to 3 years postoperatively | No |
Secondary | Improvement in Macular Edema on Optical Coherence Tomography and Color Photos | 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. | baseline (preoperatively) to 3 years postoperatively | No |
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