Selecting the right DME patients for long-term steroidal implants

September 24, 2016

An increasing number of treatment options have given patients facing diabetic macular edema (DME) new hope in the face of this chronic, progressive, and blinding disease. Experience and time have shown us there is not a one-size-fits-all solution for patients with DME. To get the results we want, we need to screen our patients and match them with the treatment protocol best suited to their needs.

Editor’s Note: Welcome to “Eye Catching: Let's Chat,” a blog series featuring contributions from members of the ophthalmic community. These blogs are an opportunity for ophthalmic bloggers to engage with readers with about a topic that is top of mind, whether it is practice management, experiences with patients, the industry, medicine in general, or healthcare reform. The series continues with this blog by Joshua Mali, MD, a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, FL. The views expressed in these blogs are those of their respective contributors and do not represent the views of Ophthalmology Times or UBM Medica.

 

An increasing number of treatment options have given patients facing diabetic macular edema (DME) new hope in the face of this chronic, progressive, and blinding disease. Experience and time have shown us there is not a one-size-fits-all solution for patients with DME. To get the results we want, we need to screen our patients and match them with the treatment protocol best suited to their needs.

Selecting the right candidate makes all the difference

Anti-VEGF therapy is typically the first line of defense against DME. Accepted as a well-tolerated and effective regimen, there remain two major reasons why we still need alternative treatments. First, the frequency and expense of this treatment can potentially become burdensome on patients, the healthcare system, and providers. The injection schedule maintained in clinical trials is rarely adhered to in the actual clinic precisely because it is a huge burden. In addition, not all patients respond ideally to anti-VEGF therapy. New data indicates that we can determine within the first three injections whether patients will have a successful or a limited response to anti-VEGF therapy. Rather than continue a sub-optimal treatment plan, we must consider different treatment options such as steroids, focal laser photocoagulation, micropulse laser, or a combination of these therapies. Without an alternative treatment, we risk leaving vision on the table for this subset of patients.

There are two major criteria to contemplate prior to beginning a steroid regimen: potential cataract development and increased IOP. When considering steroids, pseudophakic patients are the best candidates. However, I will consider the risks and benefits with phakic patients. For example, if the phakic patient is older and is not responding to any other treatment modality, the potential of advancing a cataract may not be more important than the damage being caused by the macular edema that possibly only responds to corticosteroids. In addition, I consider using a fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) preoperatively in stable phakic DME patients that are undergoing cataract surgery to help blunt any postoperative rise in DME.  

 

A clinically significant increase in IOP due to steroids is possible in some patients and is simply known as a “steroid response.” Patients with a history of glaucoma and a cup to disc ratio > 0.8 are also contraindicated. In my practice, I rule out patients with a clinically significant increase in IOP in response to either a topical or intravitreal steroid. While I prefer to exercise caution rather than treat increases in IOP with another pharmacological intervention on top of the steroid, patients must be evaluated on an individual basis. If the patient is insufficiently responsive to anti-VEGF or laser therapies, do you let the retina deteriorate rather than risk a manageable IOP rise?

Additionally, patients with a compromised lens capsule or zonular dehiscence caused by trauma or prior procedures/treatments do not make ideal candidates for these types of implants. Although unusual, capsular compromise or zonular dehiscence might be a pathway for the implant to migrate into the anterior chamber. Finally, I exclude patients sensitive to floaters. Although none of my patients thus far have complained of floaters as a side effect of the implant, it is a theoretical risk.

To determine the subset of patients likely to experience an unacceptable increase in IOP, I inject a shorter term (clinical efficacy typically up to six months), bioerodable intravitreal steroid implant (Ozurdex, Allergan) to ensure the patient can tolerate the sustained administration of steroids. I prefer to test my patients using the short-term implant rather than with just a topical steroid because it offers the best simulation of how the eye will respond to a long-term intravitreal steroid. If the patient has a good response to the implant without a significant rise in pressure, I can safely conclude they will do well with a longer-term corticosteroid treatment.

For patients meeting the treatment criteria, a long-term steroidal treatment, (such as Iluvien, Alimera Sciences) is an attractive option. The nonbioerodable implant is designed to deliver a continuous microdose of fluocinolone acetonide (FAc) to treat DME. Designed specifically for intraocular use, the tiny implant (3.5 mm x 0.37 mm) lasts for 36 months and may possibly eliminate, or at least significantly reduce, the need for and frequency of anti-VEGF or steroid injections.

 

 

 

Using the implant in a real patient

Here are some photographs displaying the implant in one of my first recipients:

Fundus montage displaying the implant in vitreousSlit lamp photograph displaying the implant

 

Lighten the burden

The bioerodable implant offers my patients an alternative treatment when anti-VEGF therapy is not sufficient. With the long-acting corticosteroid implant, patients once consigned to severe visual impairment now have another good option. This long-term treatment lightens the burden of frequent office visits and injections while still producing outcomes comparable to existing therapies. My patients gain independence, and I am rewarded with grateful patients and knowing that I have helped improve their lives.

 

Joshua Mali, MD, is a vitreoretinal surgeon at The Eye Associates, a private multispecialty ophthalmology practice in Sarasota, Florida. He can be reached at 941-792-2020. He is currently a consultant and shareholder at Alimera Sciences and a consultant at Allergan, where he also conducts research and receives clinical study funding.