Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Glenn Jaffe, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00636493
First received: February 27, 2008
Last updated: December 11, 2012
Last verified: December 2012
  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 Phase
Retinal Vein Occlusion
Device: fluocinolone acetonide (Retisert Implant)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of a Sustained-Release Fluocinolone Implant for Treatment of Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ 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 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ 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 ]

Enrollment: 30
Study Start Date: October 2002
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vein Occlusion Eye
Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device
Device: fluocinolone acetonide (Retisert Implant)
sustained release device consisting of 0.59 mg of fluocinolone acetonide
Other Name: Retisert Implant, Bausch and Lomb, Rochester, NY

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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636493

Locations
United States, North Carolina
Duke University 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
  More Information

Publications:
Responsible Party: Glenn Jaffe, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00636493     History of Changes
Other Study ID Numbers: Pro00010864 (3964)
Study First Received: February 27, 2008
Last Updated: December 11, 2012
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:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fluocinolone Acetonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014