Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)

Completed · Early Phase 1

Conditions studied: Retinal Vein Occlusion

In brief

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.

Key facts

Study ID

NCT00636493

Run by

Glenn Jaffe

People needed

30

Starts

2002-10-01

Expected to finish

2009-05-01

Last updated by the study team

2012-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Duke University Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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