BOSTON -- Fluocinolone acetonide implants slowed the progression of diabetic retinopathy in treated eyes compared with eyes not treated with the steroid implant, researchers reported here.
Overall, a significantly lower portion of eyes treated with 0.2 μg/day fluocinolone acetonide (FAc) implants progressed to proliferative diabetic retinopathy, a more severe form of the disease, within 36 months compared with fellow eyes (12.5% vs 22.3%, P=0.0027), reported Raymond Iezzi, MD, of the Mayo Clinic in Rochester, Minn., and colleagues.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Because these implants deliver a continuous micro-dose of steroid not measurable systemically, fellow-eye controlled studies "allowed us to minimize the effects of inter-subject variation in systemic disease," Iezzi said in a presentation at the American Society of Retina Specialists meeting.
Iezzi's group performed a subgroup analysis of the prospective FAME trials. The examined the effect of FAc implants on the in patients with diabetic macular edema.
This study examined patients treated with FAc implants with matching bilateral baseline ETDRS multi-step diabetic retinopathy severity scores over the course of 36 months.
Iezzi noted that they looked at diabetic retinopathy scores at baseline and diabetic macular edema was "not considered," nor was bilateral diabetic macular edema an exclusion criteria for the study.
Iezzi said that the FAME trial "allowed the patient to be treated with anything, including anti-VEGF [anti-vascular endothelial growth factor] therapies, laser or steroid."
In addition to less progression in the overall patient group, a significantly smaller portion of patients with a moderate to severe non-proliferative diabetic retinopathy (defined as a score from 47 to 53) and treated with low-dose FAc progressed to proliferative diabetic retinopathy within 36 months versus the fellow-eye (15.6% vs 30.1%, P=0.0105).
Iezzi's group also found a significantly smaller portion of patients had worsening diabetic retinopathy based on a ≥3 step change in diabetic retinopathy severity score over 36 months (0.5% in FAc-treated eyes vs 3.8% in fellow eye, P=0.0143). Similar results were seen based on a change in ≥2 step diabetic retinopathy severity score (5.5% in FAc-treated eyes vs 10.4% in fellow eye, P=0.0290). Time to first proliferative diabetic retinopathy event was also significantly shorter in fellow eyes vs FAc-treated eyes.
"These effects are as powerful as the effects of anti-VEGF injections," Iezzi said. "A continuous low-dose of fluocinolone acetonide may be neuroprotective, as has been seen in animal models."
He added that before the drug was commercially available as a product for patients, it was available in the laboratory, where he and his fellow researchers were able to insert these implants into rats.
"These implants target an inflammatory pathway, not a VEGF approach," Iezzi added. "Neuroinflammation is not talked about in diabetic retinopathy, but it is one of the key drivers in damage to blood vessels."
Primary Source
American Society of Retina Specialists
Iezzi R, et al "Inhibition of diabetic retinopathy progression by 0.2 ug/day fluocinolone acetonide implants: A fellow-eye controlled analysis" ASRS 2017.