Prospective study of a fluocinolone acetonide implant for chronic macular edema from central retinal vein occlusion: thirty-six-month results.

PURPOSE: To assess long-term visual outcomes and adverse events from a fluocinolone acetonide (FA) sustained drug delivery implant in eyes with chronic macular edema from central retinal vein occlusion (CRVO).

DESIGN

Prospective interventional case series.

PARTICIPANTS

A total of 24 eyes of 23 subjects with vision loss associated with chronic macular edema from CRVO.

INTERVENTION: Implantation of an intravitreal FA sustained drug delivery system.

MAIN OUTCOME MEASURES: The primary outcome measure was mean Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity letter score at 36 months after implantation. Secondary outcome measures included number of subjects with ≥ 10-letter improvement in ETDRS letter score, central foveal thickness (CFT), total macular volume, and intraocular pressure (IOP).

RESULTS

At 1, 2, and 3 years after implantation, mean visual acuity showed gains of 4.5 (P = 0.52), 8.2 (P = 0.07), and 3.4 (P = 0.64) letters, respectively, and 32%, 56%, and 50% of study eyes, respectively, showed at least a 10-letter gain in ETDRS score. At these same time points, mean CFT improved by 247 (44%; P = 0.002), 212 (38%; P < 0.001), and 250 μm (45%; P<0.001), respectively. During the study period, all phakic eyes ultimately underwent cataract extraction, and 5 eyes underwent glaucoma surgery.

CONCLUSIONS

The FA drug delivery system provided sustained visual acuity and anatomic benefit in patients with macular edema from CRVO, and it has promise as a therapeutic option for selected patients with this condition. The main complications were cataract and elevated IOP.

FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article.