Study: Fluocinolone acetonide 0.2 µg/day reduced DR progression

February 15, 2016

Treatment with fluocinolone acetonide 0.2 µg/day significantly reduced progression to proliferative diabetic retinopathy (PDR) in patients who were part of the FAME trials1,2 and had visual acuity loss due to diabetic macular edema (DME), according to Charles C. Wykoff, MD, PhD.

Reviewed by Charles C. Wykoff, MD, PhD 

Take-home message: Progression to proliferative diabetic retinopathy was reduced in patients treated with fluocinolone acetonide 0.2 µg/day. 

Houston-Treatment with fluocinolone acetonide 0.2 µg/day significantly reduced progression to proliferative diabetic retinopathy (PDR) in patients who were part of the FAME trials1,2 and had visual acuity loss due to diabetic macular edema (DME), according to Charles C. Wykoff, MD, PhD.

“The duration of continuous steroid exposure during the FAME trials provides a unique opportunity to address the clinical question of the effect of corticosteroids on the progression to PDR,” said Dr. Wykoff, Retina Consultants of Houston, Blanton Eye Institute and Houston Methodist Hospital, Houston.

Treatment options for DME have expanded in the past decade, with four drugs now approved by the FDA for DME:

  •       ranibizumab (Lucentis, Genentech)

  •       aflibercept (Eylea, Regeneron)

  •       fluocinolone acetonide (Iluvien, Alimera Sciences)

  •       dexamethasone (Ozurdex, Allergan)

“Through multiple phase III trials of DME in eyes with diabetic retinopathy, we’ve learned that VEGF inhibition can dramatically blunt the progression to PDR,” Dr. Wykoff said.

Do corticosteroids have a similar impact?

 

Still, the question remains as to whether corticosteroids can have a similar impact on progression to PDR.

The fluocinolone acetonide implant was studied in the FAME A and B trials for the management of DME, in which 956 eyes with persistent edema despite at least one previous macular laser treatment were randomly assigned to sham control or one of two doses of fluocinolone acetonide with a 2-year primary endpoint and a 3-year total trial duration.

At baseline, 60% of patients in the study had nonproliferative diabetic retinopathy, and 40% had PDR.

“My objective in this subanalysis was to evaluate the rate of progression to PDR in sham eyes versus fluocinolone-acetonide treated eyes,” Dr. Wykoff said.

To achieve this, progression was defined as Reading Center (University of Wisconsin-Madison)-determined development of PDR, application of pan-retinal photocoagulation for PDR, or pars plana vitrectomy performed to treat PDR at the masked investigator’s discretion.

“In the complete FAME data set at month 36, 31% of sham-controlled eyes and 17% of the fluocinoline acetonide 0.2 µg/day treated eyes progressed to PDR (p < 0.001) with a mean of 1.3 injections of the implant,” Dr. Wykoff said.

The magnitude of this effect on blunting the progression to PDR was similar to that observed with monthly anti-VEGF treatments.3

At every time point after 6 months, the difference in the rate of progression to PDR was statistically significant, Dr. Wykoff said.

The beneficial effect of fluocinolone treatment was particularly evident among eyes with a diagnosis of chronic DME at FAME baseline.

“In this population,” he said, “the rate of progression to PDR was reduced to 14% at 3 years compared with 31% in the control arm.”

 

References

1. Campochiaro PA, Brown DM, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology. 2011;118:626-635.

2. Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery flucinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119:2125-2132.

3. Ip MS, et al. Long-term effects of therapy with ranibizumab on diabetic retinopathy severity and baseline risk factors for worsening retinopathy. Ophthalmology. 2015;122:367-374.

 

 

Charles C. Wykoff, MD, PhD

E: ccwmd@houstonretina.com

This article was adapted from Dr. Wykoff’s presentation during Retina Subspecialty Day at the 2015 meeting of the American Academy of Ophthalmology. Dr. Wykoff did not indicate any proprietary in the subject matter.