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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00952614
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : June 30, 2014
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Glenn Jaffe, Duke University

Study Description
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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
Central Retinal Vein Occlusion Device: fluocinolone acetonide (Retisert Implant, Bausch and Lomb) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Study Start Date : October 2002
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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Arms and Interventions
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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 Name: Retisert Implant, Bausch and Lomb, Rochester, NY


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts [ Time Frame: baseline (preoperatively) to 3 years postoperatively ]
    Outcome measure based on eyes at time points with 10-letter ETDRS score improvement


Secondary Outcome Measures :
  1. Improvement in Macular Edema on Optical Coherence Tomography and Color Photos [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952614


Locations
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United States, North Carolina
Duke Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Glenn Jaffe
Bausch & Lomb Incorporated
Investigators
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Principal Investigator: Glenn J Jaffe, MD Duke Eye Center, DUMC
More Information
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Responsible Party: Glenn Jaffe, Professor, Duke University
ClinicalTrials.gov Identifier: NCT00952614    
Other Study ID Numbers: Pro00007284
7300 ( Other Identifier: Duke legacy protocol ID )
First Posted: August 6, 2009    Key Record Dates
Results First Posted: June 30, 2014
Last Update Posted: August 6, 2014
Last Verified: August 2014
Keywords provided by Glenn Jaffe, Duke University:
retinal vein occlusion
sustained drug delivery implant
steroid
macular edema
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs