Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO) - Full Text View

Sponsor:	Duke University
Collaborator:	Bausch & Lomb, Inc.
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00636493

Purpose

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.

Condition	Intervention
Retinal Vein Occlusion	Device: fluocinolone acetonide sustained release device (Retisert Implant)

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of a Sustained-Release Fluocinolone Implant for Treatment of Retinal Vein Occlusion

Resource links provided by NLM:

MedlinePlus related topics: Edema

Drug Information available for: Fluocinolone acetonide Fluocinolone

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Change from baseline in visual acuity using 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Elevations in 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 ] [ Designated as safety issue: Yes ]
Quality of life scores using the 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2002
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vein Occlusion Eye: Experimental Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device	Device: fluocinolone acetonide sustained release device (Retisert Implant) sustained release device consisting of 0.59 mg of fluocinolone acetonide

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636493

Contacts

Contact: Glenn J Jaffe, MD

(919) 684-4458

jaffe001@mc.duke.edu

Locations

United States, North Carolina
Duke University Eye Center	Recruiting
Durham,, North Carolina, United States, 27710
Contact: Glenn J Jaffe, MD 919-684-4458 jaffe001@mc.duke.edu

Sponsors and Collaborators

Duke University

Bausch & Lomb, Inc.

Investigators

Principal Investigator:

Glenn J Jaffe, MD

Duke Eye Center, DUMC

More Information

Publications:

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. Epub 2006 May 9.

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.

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.

Responsible Party:	Duke Eye Center, DUMC ( Glenn J. Jaffe, MD )
Study ID Numbers:	3964
Study First Received:	February 27, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00636493 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duke University:

retinal vein occlusion
sustained drug delivery implant
steroid
macular edema

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Fluocinolone Acetonide
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Glucocorticoids
Hormones

Pharmacologic Actions
Thrombosis
Embolism and Thrombosis
Therapeutic Uses
Retinal Vein Occlusion
Venous Thrombosis
Cardiovascular Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2009