Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)

NCT00636493 | Completed Early Phase 1 DMC

• 1 other identifier: Pro00010864 (3964)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinal Vein Occlusion

Keywords

retinal vein occlusion; sustained drug delivery implant; steroid; macular edema

Outcome Measures

Primary Outcomes (1)

• Change from baseline in visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts

  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

Secondary Outcomes (4)

• Amount of macular edema on optical coherence tomography and color photos

  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

• 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.

  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

• Quality of life scores using the Visual Functioning (VF)-25 and SF-36 surveys

  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

• Ocular adverse events (vitreous hemorrhage, retinal detachment, cataract, endophthalmitis, drug toxicity)

  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

Study Arms (1)

Vein Occlusion Eye

EXPERIMENTAL

Eye with retinal vein occlusion receiving fluocinolone acetonide sustained drug delivery device

Device: fluocinolone acetonide (Retisert Implant)

Interventions

fluocinolone acetonide (Retisert Implant) DEVICE

sustained release device consisting of 0.59 mg of fluocinolone acetonide

Also known as: Retisert Implant, Bausch and Lomb, Rochester, NY

Vein Occlusion Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenn Jaffe: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• 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. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.

  PMID: 16690128 BACKGROUND

• 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. doi: 10.1016/j.ophtha.2005.03.013.

  PMID: 15921758 BACKGROUND

• 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. doi: 10.1016/s0161-6420(00)00466-8.

  PMID: 11054326 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Glenn J Jaffe, MD

  Duke Eye Center, DUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 14, 2008
• Study Start: October 1, 2002
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 12, 2012

Record last verified: 2012-12

Locations

US (1)