Status:
COMPLETED
Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
Lead Sponsor:
Glenn Jaffe
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 vi...
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00636493
Start Date
October 1 2002
End Date
May 1 2009
Last Update
December 12 2012
Active Locations (1)
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1
Duke University Eye Center
Durham, North Carolina, United States, 27710