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Educate diabetes patients on new DME, DR treatments
The CDC’s National Diabetes Statistics Report 2017 shows that half of Americans have diabetes or are at risk for it. Specifically, this sight-threatening condition affects more than 30.3 million, or one in 10 Americans, with about 7.2 million adults unaware they have it or undiagnosed and another 84.1 million adults pre-diabetic, according to the report.
What’s more, diabetic eye disease – diabetic retinopathy (DR) and diabetic macular edema (DME), the leading cause of severe vision loss and blindness in working age adults – is projected to climb from 7.7 million people to 11 million by 2030, according to the NEI.
In recent years, anti-VEGF therapy has become the standard of care for centered-involved DME and DR. Highlights from the recent American Society of Retinal Specialists meeting revealed the long-term success of these agents in DME treatment, the use of the Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences) implant and a novel therapy using integrin peptide therapy in preserving or improving vision.
It’s important to be aware of these new treatment options for both DME and DR in preventing the onset and progression of vision loss, so you can educate your patients before you refer them for such injections.
- For more information:
- Sherrol Reynolds, OD, FAAO, is an associate professor at Nova Southeastern University, a clinical attending in the diabetes and macular clinic and Primary Care Optometry News Editorial Board member. She can be reached at sreynold@nova.edu.
Disclosure: Reynolds reports no relevant financial disclosures.
Anti-VEGF for DME
On behalf of the Diabetic Retinopathy Clinical Research Network, John A. Wells, MD, FACS, gave a new analysis of eyes with persistent DME in the Protocol T trial.
“Even in the presence of chronic, persistent DME, visual acuity gains are the norm, and vision loss is uncommon,” Wells said in a presentation at the American Society of Retina Specialists meeting.
The study was undertaken to assess visual and anatomic effects of Eylea (aflibercept, Regeneron), Avastin (bevacizumab, Genentech) and Lucentis (ranibizumab, Genentech) in eyes with persistent diabetic macular edema through 2 years.
“We wanted to know what happens to this group of eyes with DME at 6 months,” Wells said. “What we found was that at baseline, the median vision score and the Snellen equivalent were similar in all three groups, regardless of whether there was persistent DME or not at 24 weeks.”
Eyes with persistent DME at 24 weeks had less vision gain than eyes that had resolution of DME, except in the bevacizumab group, where there was no difference, he said.
“We saw a similar trend for 10-letter gainers, and fortunately the rates of vision loss were very low across all three treatment arms,” he said.
From 24 weeks to 2 years, there was a continued slow reduction in eyes with DME over the ensuing 18 months, although eyes in the bevacizumab group were less likely to have resolution, Wells said. There was no statistical difference between rates of resolution at 2 years between aflibercept and ranibizumab.
When comparing vision gains at 2 years, Wells said, “There was this paradoxical situation where eyes in the aflibercept group with persistent DME had more vision gain than those that had resolution of their DME. There was no difference within the bevacizumab group, and, more like you would expect, eyes within the ranibizumab group with resolution of DME had more vision gain than had persistent DME. We saw a similar trend for 10-letter gainers, and, again, the rates of vision loss were low regardless of treatment arm or DME status.”
Iluvien improves central retinal thickness
Central retinal thickness values improved after exposure to fluocinolone acetonide implant in eyes previously treated for DME, according to a study.
However, steroid-induced ocular hypertension can occur despite a negative steroid challenge at baseline, with the baseline use of topical glaucoma therapy potentially confounding assessment of the steroid response, Sumit P. Shah, MD, FACS, said in a paper presentation at the American Society of Retina Specialists meeting.
Shah and colleagues undertook a retrospective chart review of 26 eyes of 20 patients receiving a single Iluvien intravitreal implant after previous treatment for DME with a different therapy. Before implanting the fluocinolone acetonide agent, a steroid challenge was performed with dexamethasone implant in 25 of the eyes and with triamcinolone acetonide in one eye.
Mean IOP was reduced from 17.7 mm Hg at baseline to 15.7 mm Hg at 1 year (P = .02).
“Although this was statistically lower, this was confounded by the concurrent management of IOP increase in those patients developing ocular hypertension,” Shah said.
Differences in visual acuity between baseline (20/75) and 1-year follow-up (20/69) was not statistically significant, he said. There was a statistically significant difference in mean central retinal thickness, however, from 403.4 µm to 297.5 µm (P = .01).
“Despite the growing number of available treatments for DME, the treatment burden is high, and there is a subset of patients that can be difficult to treat,” Shah said.
Novel integrin peptide therapy for DME
Sequential therapy with 1 mg ALG-1001 yielded equivalent visual acuity gains as treatment with bevacizumab monotherapy in patients with DME, according to a study.
“The safety profile was excellent. There was very little in the way of [serious adverse events] at all,” David Boyer, MD, said at the American Society of Retina Specialists meeting, where he delivered topline results for the phase 2 stage 2 DEL MAR study.
The DEL MAR study was undertaken to investigate the safety and efficacy of Luminate (ALG-1001, Allegro), a synthetic oligopeptide that inhibits integrin receptors and arrests aberrant blood vessel growth in neovascular tissue in patients with diabetic retinopathy.
In stage 1 of the study, best corrected visual acuity improvements were equivalent between treatment with ALG-1001 and treatment with Avastin.
In this stage 2 study, safety and efficacy of ALG-1001 with bevacizumab pretreatment or ALG-1001 combined with bevacizumab were compared.
Eighty patients were included in five arms of the study: 0.5 mg or 1 mg of ALG-1001 with one dose of bevacizumab pretreatment; 0.5 mg or 1 mg of ALG-1001 combined with bevacizumab; and bevacizumab monotherapy control.
Primary endpoint was best corrected visual acuity equivalence in both sequential therapy arms at 20 weeks.
“The study met the primary endpoint of best corrected visual acuity in both the sequential therapy arms, so 1 mg and 0.5 mg ALG-1001. The 1 mg ALG-1001 sequential treatment showed gains that were equivalent to bevacizumab given monthly,” Boyer said.
No additional benefit was seen in the combined ALG-1001 and bevacizumab arms. – by Patricia Nale, ELS
- References:
- Boyer D. Topline results from prospective, double-masked phase 2b clinical trial evaluating ALG-1001 (Luminate) compared to bevacizumab in patients with DME. Presented at: American Society of Retina Specialists annual meeting; Aug. 11-15, 2017; Boston.
- CDC. National Diabetes Statistics Report, 2017. https://www.cdc.gov/diabetes/data/statistics/statistics-report.html. Updated July 17, 2017. Accessed November 20, 2017.
- National Eye Institute. Diabetic eye disease projected to increase among U.S. population. https://www.nei.nih.gov/sites/default/files/nehep-pdfs/GM_DED_drop-in%20article_2014.pdf. Accessed November 20, 2017.
- Shah SP, et al. One-year results of fluocinolone acetonide intravitreal implant for diabetic macular edema in highly treated eyes. Presented at: American Society of Retina Specialists annual meeting, Aug. 11-15, 2017; Boston.
- Wells JA. Persistent macular thickening following intravitreous aflibercept, bevacizumab or ranibizumab for center-involved DME with vision impairment. Presented at: American Society of Retina Specialists annual meeting, Aug. 11-15, 2017; Boston.
Disclosures: Boyer reports he is a consultant for Allegro. Shah reports he is a consultant for Alimera Sciences, Genentech and Regeneron Pharmaceuticals. Wells reports he is a consultant for Genentech and an investigator for Genentech and Regeneron.