N/A
N=30
A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
Central Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00952614 ↗Enrolled (actual)
30
Serious AEs
10.3%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts — 12.5; 14; 13.5 letters read correctly
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fluocinolone acetonide (Retisert Implant, Bausch and Lomb) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Glenn Jaffe
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts |
12.5; 14; 13.5 | — |
| SECONDARY Improvement in Macular Edema on Optical Coherence Tomography and Color Photos |
10.4 | — |
Summary
The purpose of this study is to determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of central retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.
Eligibility Criteria
Inclusion Criteria
Patients are eligible to receive an implant if they met all the following criteria:
- A history of central 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 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.
Data sourced from ClinicalTrials.gov (NCT00952614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.