Fluocinolone Acetonide Implant Decreases Treatment Burden in DME

JULY 22, 2018
Matt Hoffman
Shaina M. Rubino, MD
Intravitreal injection of a 0.19-mg fluocinolone acetonide implant (FAc) have shown to hold promise in decreasing the burden of treatment in patients with diabetic macular edema (DME).

In research presented at the 36th annual meeting of the American Society of Retinal Specialists (ASRS) in Vancouver, British Columbia, the use of FAc decreased the need for additional anti-vascular endothelial growth factor (anti-VEGF) injections in 50% (n = 7) of the treated eyes after implantation.

While the authors noted that the study size was a limitation, the findings are promising for a condition that has a high level of treatment burden, as most patients require monthly anti-VEGF injections to combat their disease. “We hypothesized that patients who fail therapy with VEGF inhibitors and are treated with FAc often require rescue therapy, but have a significant reduction in treatment burden,” lead author Shaina M. Rubino, MD, and colleagues wrote.

In the retrospective study, Rubino, a fellow at VitreoRetinal Surgery in Pennsylvania, and collaborators reviewed the outcomes of 14 eyes with DME that had previously failed therapy with a VEGF inhibitor and were afterward implanted with the long-acting intravitreal steroid. Patients were followed and treated for at least 1-year pre-FAc implantation. The average follow-up was 525 days.

The results revealed that the number of anti-VEGF injections patients underwent per 28 days decreased from 0.322 to 0.047, a significant reduction (P = .0001). Rubino and others noted that “long-acting steroid implants are available for patients with DME and significantly decrease treatment burden,” but did acknowledge the caveat that these patients “should be followed for management of side effects and potential adjuvant therapy.”

From baseline, 6 patients gained >2 lines of visual acuity after injection, while 6 more gained or lost ≤2 lines and 3 lost >2 lines, resulting in no significant differences as measured by logMAR (P = .514). Pre-injection with the FAc, 1 patient had vision ≥20/40, with that number increasing to 4 post-injection, however, the number of patients with visual acuity <20/40 but ≥20/80 decreased from 9 to 6 post-injection. Additionally, the number of patients with visual acuity worse than 20/200 increased from 2 to 3 after the implant.

Although, both central foveal thickness decreased, from 446 µm to 331 µm (P = .01), and intraocular pressure decreased, from 16.2 mm Hg to 17.6 mm Hg (P = .04). Rubino and colleagues noted that none of the patients required surgical intervention for the management of intraocular pressure, despite 2 eyes requiring additional topical ocular hypotensive medications.

Overall, 10 eyes (73%) were pseudophakic at the time of FAc implantation. As the data collection is still ongoing, the investigators wrote that “13% of the remaining phakic patients underwent [cataract extraction with intraocular lens], 7% are scheduled for surgery, 7% are phakic and stable.”

In terms of events, a single patient had a combined tractional and rhegmatogenous retinal detachment related to a severe case of proliferative diabetic retinopathy, another required a tube shunt revision related to tube exposure, and a third patient demonstrated serial migration of the implant into the anterior chamber. Additionally, 2 patients that experienced “excellent” results received a second injection at day 884 and 767, respectively. Due to this, the authors remarked that “the likelihood of future interventions and related financial impact should be considered when evaluating available treatment options.”

Rubino and her fellow investigators concluded with a hope that the findings would help inform physician and patient expectations about FAc and observed that additional data collection could assist in the prediction of which patients would be more likely to require rescue therapy.

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