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A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

Primary Purpose

Central Retinal Vein Occlusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluocinolone acetonide (Retisert Implant, Bausch and Lomb)
Sponsored by
Glenn Jaffe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring retinal vein occlusion, sustained drug delivery implant, steroid, macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retisert for Retinal Vein Occlusion

Arm Description

0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 4, 2009
Last Updated
August 1, 2014
Sponsor
Glenn Jaffe
Collaborators
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00952614
Brief Title
A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Official Title
A Pilot Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
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
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion
Keywords
retinal vein occlusion, sustained drug delivery implant, steroid, macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retisert for Retinal Vein Occlusion
Arm Type
Experimental
Arm Description
0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion
Intervention Type
Device
Intervention Name(s)
fluocinolone acetonide (Retisert Implant, Bausch and Lomb)
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
Description
Outcome measure based on eyes at time points with 10-letter ETDRS score improvement
Time Frame
baseline (preoperatively) to 3 years postoperatively
Secondary Outcome Measure Information:
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

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 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.
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 Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

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