A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts [baseline (preoperatively) to 3 years postoperatively]
Outcome measure based on eyes at time points with 10-letter ETDRS score improvement
Secondary Outcome Measures
- Improvement in Macular Edema on Optical Coherence Tomography and Color Photos [baseline (preoperatively) to 3 years postoperatively]
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.
Eligibility Criteria
Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Eye Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Glenn Jaffe
- Bausch & Lomb Incorporated
Investigators
- Principal Investigator: Glenn J Jaffe, MD, Duke Eye Center, DUMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00007284
- 7300
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Twenty nine (29) participants were consented, 30 eyes. Of the 29 consented, there were 23 subjects included in the data pool of which one subject had both eyes included in the study. |
| Arm/Group Title | Retisert for Retinal Vein Occlusion |
|---|---|
| Arm/Group Description | 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide |
| Period Title: Overall Study | |
| STARTED | 30 |
| Participants Started Treatment | 30 |
| COMPLETED | 23 |
| NOT COMPLETED | 7 |
Baseline Characteristics
| Arm/Group Title | Retisert for Retinal Vein Occlusion |
|---|---|
| Arm/Group Description | 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide |
| Overall Participants | 30 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
68
(9.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
11
36.7%
|
| Male |
19
63.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
30
100%
|
Outcome Measures
| Title | Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts |
|---|---|
| Description | Outcome measure based on eyes at time points with 10-letter ETDRS score improvement |
| Time Frame | baseline (preoperatively) to 3 years postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Retisert for Retinal Vein Occlusion |
|---|---|
| Arm/Group Description | 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years. |
| Measure Participants | 23 |
| Change in ETDRS @ 1 year after implant |
12.5
|
| Change in ETDRS @ 2 years after implant |
14
|
| Change in ETDRS @ 3 years after implant |
13.5
|
| Title | Improvement in Macular Edema on Optical Coherence Tomography and Color Photos |
|---|---|
| Description | 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. |
| Time Frame | baseline (preoperatively) to 3 years postoperatively |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Retisert for Retinal Vein Occlusion |
|---|---|
| Arm/Group Description | 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide |
| Measure Participants | 23 |
| Mean (Inter-Quartile Range) [improvement in TMV/mm^3] |
10.4
|
Adverse Events
| Time Frame | 3 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Retisert for Retinal Vein Occlusion | |
| Arm/Group Description | 0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide | |
All Cause Mortality |
||
| Retisert for Retinal Vein Occlusion | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Retisert for Retinal Vein Occlusion | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/29 (10.3%) | |
| General disorders | ||
| Death | 3/23 (13%) | 3 |
Other (Not Including Serious) Adverse Events |
||
| Retisert for Retinal Vein Occlusion | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/29 (3.4%) | |
| Infections and infestations | ||
| Endophthalmitis | 1/29 (3.4%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Glenn J. Jaffe, MD |
|---|---|
| Organization | Duke University Medical Center |
| Phone | 919-684-4458 |
| jaffe001@mc.duke.edu |
- Pro00007284
- 7300