Real-world setting proving positive for intravitreal implant for DME

March 1, 2015

One center’s initial post-marketing experience with the fluocinolone acetonide intravitreal implant 0.19 mg demonstrates favorable outcomes and good patient acceptance.

Take-home message: One center’s initial post-marketing experience with the fluocinolone acetonide intravitreal implant 0.19 mg demonstrates favorable outcomes and good patient acceptance.

By Cheryl Guttman Krader; Reviewed by Bushra Mushtaq, FRCS

Birmingham, UK-Initial post-marketing experience with the fluocinolone acetonide intravitreal implant 0.19 mg (Iluvien, Alimera Sciences) indicates it is a valuable addition for the treatment of diabetic macular edema (DME), according to Bushra Mushtaq, FRCS.

Over a period of about 9 months, the fluocinolone implant has been used to treat DME in 23 eyes of 18 patients presenting to the medical retina department at Birmingham and Midlands Eye Centre, Birmingham, UK.

All patients had failed prior therapy and had very chronic, advanced macular changes associated with DME duration of 2 to 7 years, said Dr. Mushtaq, consultant ophthalmologist, and director, medical retina services at the center.

After follow-up ranging from 1 week to 9 months, mean subfoveal thickness decreased from 513 µm pre-implantation to 376 µm post-implantation. Near complete drying of the macula was achieved in 11 eyes, and 6 eyes still had significant DME, but follow-up was still relatively early for some of those cases (range, 5 days to 2 months).

Visual acuity improved as well in most eyes followed to 6 weeks or longer, with some eyes gaining up to 4 Snellen lines. Only 3 eyes had no improvement on optical coherence tomography or in their visual acuity.

“The 3 eyes that did not achieve flattening of the macula had very chronic DME and had failed prior treatment with laser, anti-vascular endothelial growth factor (VEGF) injections, and even intravitreal triamcinolone,” Dr. Mushtaq said.

However, even these eyes exhibited some benefit from treatment with the fluocinolone implant as patients noted improvement in quality of vision, she said.

“Moreover, all of the patients have been very happy because of the fact that the long-acting fluocinolone implant allows for a reduced visit burden,” Dr. Mushtaq said.

Instead of having to return for treatment monthly, patients who receive the fluocinolone acetonide implant are scheduled for follow-up visits every 3 months after initially being seen at 1 to 2 weeks and then 6 to 8 weeks post-implantation, she explained.

 

Anatomic, functional gains

Dr. Mushtaq observed that anatomic and functional improvements occurred rapidly after the implantation procedure. Most patients demonstrated marked improvements within just 2 weeks and further benefit at 6 weeks.

“Based on my experience so far, it seems that if there is no benefit by 6 weeks, improvement is unlikely to occur with longer follow-up,” Dr. Mushtaq said.

So far, the only post-implantation adverse event has been elevated IOP in one eye (28 mmHg), which has been controlled with topical medication.

Although Dr. Mushtaq first began using the fluocinolone implant as a last resort option for patients with advanced, refractory DME, as she gained confidence, its use was expanded to include eyes with better macular structural integrity and visual prognosis as well as for patients who had failed only laser therapy and expressed a desire to avoid monthly anti-VEGF injections.

In addition, she became comfortable using the fluocinolone implant bilaterally.

Dr. Mushtaq noted that follow-up for safety evaluations will continue for the eyes that did not benefit from treatment. Since safety has been favorable so far, she has no plans to explant those devices.

 

 

Bushra Mushtaq, FRCS

E: bushramushtaq@nhs.net

Dr. Mushtaq has received travel grants from Alimera Sciences, but has no other relevant financial interests to disclose.