Back to resultsFluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
Primary Purpose
Retinal Vein Occlusion
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
fluocinolone acetonide (Retisert Implant)
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring retinal vein occlusion, sustained drug delivery implant, steroid, macular edema
Eligibility Criteria
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.
Sites / Locations
- Duke University Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vein Occlusion Eye
Arm Description
Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device
Outcomes
Primary Outcome Measures
Change from baseline in visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts
Secondary Outcome Measures
Amount of macular edema on optical coherence tomography and color photos
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.
Quality of life scores using the Visual Functioning (VF)-25 and SF-36 surveys
Ocular adverse events (vitreous hemorrhage, retinal detachment, cataract, endophthalmitis, drug toxicity)
Full Information
NCT ID
NCT00636493
First Posted
February 27, 2008
Last Updated
December 11, 2012
Sponsor
Glenn Jaffe
Collaborators
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00636493
Brief Title
Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
Official Title
A Pilot Study of a Sustained-Release Fluocinolone Implant for Treatment of Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Glenn Jaffe
Collaborators
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
retinal vein occlusion, sustained drug delivery implant, steroid, macular edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vein Occlusion Eye
Arm Type
Experimental
Arm Description
Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device
Intervention Type
Device
Intervention Name(s)
fluocinolone acetonide (Retisert Implant)
Other Intervention Name(s)
Retisert Implant, Bausch and Lomb, Rochester, NY
Intervention Description
sustained release device consisting of 0.59 mg of fluocinolone acetonide
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn J Jaffe, MD
Organizational Affiliation
Duke Eye Center, DUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Eye Center
City
Durham,
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16690128
Citation
Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
Results Reference
background
PubMed Identifier
15921758
Citation
Jaffe GJ, McCallum RM, Branchaud B, Skalak C, Butuner Z, Ashton P. Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. Ophthalmology. 2005 Jul;112(7):1192-8. doi: 10.1016/j.ophtha.2005.03.013.
Results Reference
background
PubMed Identifier
11054326
Citation
Jaffe GJ, Ben-Nun J, Guo H, Dunn JP, Ashton P. Fluocinolone acetonide sustained drug delivery device to treat severe uveitis. Ophthalmology. 2000 Nov;107(11):2024-33. doi: 10.1016/s0161-6420(00)00466-8.
Results Reference
background
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Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
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