The Lowdown on Inherited Retinal

Diabetic Retinopathy

by Joanna Lee Treatment Management Updates

Recent advances in the management of diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR) were hot symposium topics at the 13th AsiaPacific Vitreo-retina Society Congress (APVRS 2019), held last November in Shanghai, China.

Singapore National Eye Centre (SNEC) Medical Director Dr. Tien-Yin Wong set the stage by presenting an overview of all the major studies for DME — such as RISE & RIDE, ETDRS, DRCR Protocol T, DRCR Protocol V — and how the results of these RCTs could be applied to clinical practices.

Overall, the studies showed that antiVEGFs improved vision with good longterm outcomes (5-year outcome with DRCR.net Protocol I; 3-year outcomes of RESTORE and VIVID/VISTA studies) as opposed to laser treatment. The visual acuity (VA) gain was about 10-12 letters.

For severe DME with poorer vision, aflibercept was shown to be superior; however, for milder DME with good vision, there appeared to be no difference among the agents. Additionally, there seems to be improvement in VA and macular thickness with the use of intravitreal triamcinolone (IVTA) and dexamethasone implant (Ozurdex, Allergan), but the VA gain is inferior to that of anti-VEGFs in clinical trials. “However, steroids are useful for pseudophakic eyes and second- or third-line therapies,” he said.

It may also be beneficial to look at the prognosis, as vision loss may not be only caused by DME — but also by macular atrophy or ischemic maculopathy.

On DME Treatment

Following that, Dr. Jun Kong looked treatment for eyes with center-involved DME and VA of 20/25. He noted the results of Protocol V 1 showed no difference in rates of VA loss (one or more lines) at two years among eyes managed with aflibercept, laser or observation. Of those three management strategies (not monotherapies), they found that at two year, eyes with VA of 20/20 (and a proportion of eyes at 20/20 or better) was significantly greater with aflibercept (77%) than observation (66%). However, the proportion of eyes with 20/25 or better was similar in each group (about 85%).

Follow-up was carefully done, with aflibercept initiated in the laser and observation groups if vision decreased by one line at two consecutive visits or more than two lines at one visit; changes on OCT did not spark aflibercept initiation. The primary outcome was a loss of five or more letters, with the reason likely to be clinically relevant in eyes with good vision, and unlikely to be due to chance variations.

To sum up, among eyes with DME and good VA, there was no significant difference in VA loss at two years in eyes that were initially managed with aflibercept, laser photocoagulation or observation. The laser or observation groups were given aflibercept only if VA had worsened.

On Improved Surgical Outcomes for TRD

Surgical outcomes of for diabetic traction retinal detachment (TRD) have been improved, according to Dr. Masahito Ohji, who talked about management of diabetic TRD. One reason for this is Alcon’s advanced ULTRAVIT Beveled High-Speed probe for microincision vitrectomy surgery (MIVS). This machine provides a closer port proximity to the retina, which allows more access to tissue planes. It also increases the cut speed up to 10,000 cuts-per-minute, while reducing vitreoretinal traction. Having this technology has also improved the understanding of DR’s pathogenesis.

In his meta-analysis of intraoperative and postoperative indices, with and without preoperative administration of anti-VEGF, Dr. Ohji said the results were very positive with very low intraoperative bleeding or frequencies of required endodiathermy. Postoperatively, the general incidence of early VH and VH clear-up time was also very low.

On Pregnancy and Diabetic Retinopathy

Dr. Mae-Lynn Bastion’s presentation, entitled “Diabetic Retinopathy in Pregnancy: A Clear and Present Danger” provides a glimpse of an ongoing investigation into this rarely discussed area of ophthalmic research. Dr. Bastion and her co-investigators embarked on a retrospective study of Malaysian cases of DR in pregnancy, believed to the first study of its kind in the country.

Practitioners often face a dilemma when encountering DR or centerinvolving DME in pregnant patients — risks of harm to the baby 2 when administering anti-VEGF injections to

the mother, some of which result in spontaneous abortions.

“There is a lack of clear evidence for administering anti-VEGFs to pregnant women,” she said. From her observations of data thus far, it is vital to perform pre-pregnancy screening of diabetics as early as possible in DR progression. There should be pregnancy testing prior to giving anti-VEGF to young female diabetics; awareness of risk factors for progression in pregnancy; and the condition should be treated as conservatively as possible. “If anti-VEGF treatment is required, try to avoid it in the first trimester of pregnancy,” she said.

On Intraretinal Fluid in DME

As little is known about the significance of intraretinal fluid in DME, Dr. Hyung Chan Kim delved into the correlation of retinal fluid volume with visual and anatomical outcomes after treatment in DME. Following his study on observing

INDUSTRY UPDATE

3D morphologic changes in AMD 3 , Dr. Kim attempted to analyze the changes in DME as well.

In his presentation entitled, “3D Analysis of Morphologic Changes with Visual Outcome in DME,” he discussed his retrospective, cross-sectional study of 65 eyes of DME patients treated with intravitreal bevacizumab (IVB). The investigated parameters were the baseline fluid volumes and best corrected visual acuity (BCVA), and DRIL (disorganized retinal inner layers), a “robust biomarker for DME”. 4 He also looked at other DME biomarkers like OCT patterns, deep capillary plexus (DCP) loss and hyperreflective foci. Treatment response during the study showed 58% of patients had a good response when the central macular thickness was reduced by more than 50 microns after anti-VEGF. The study showed how baseline inner IRF volume correlates with poor visual outcome after treatment, indicating that inner IRF volume could be a biomarker for DME.

References:

1 Baker CW, Glassman AR, Beaulieu WT, et al; DRCR Retina Network. Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial. JAMA. 2019;321(19):1880-1894.

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Polizzi S, Mahajan VB. Intravitreal Anti-VEGF Injections in Pregnancy: Case Series and Review of Literature. J Ocul Pharmacol Ther. 2015; 31(10): 605–610. Lee H, Jo A, Kim HC. Three-Dimensional Analysis of Morphologic Changes and Visual Outcomes in Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2017;58(2):1337-1345. Sun JK, Lin MM, Lammer J, et al. Disorganization of the retinal inner layers as a predictor of visual acuity in eyes with center-involved diabetic macular edema. JAMA Ophthalmol. 2014;132(11):1309-1316.

Editor’s Note:

The 13 th Asia-Pacific Vitreo-retina Society Congress (APVRS 2019) was held in Shanghai, China, on November 22-24, 2019. Media MICE Pte Ltd, PIE magazine’s parent company was the Official Media Partner at APVRS 2019. Reporting for this story also took place at APVRS 2019.

Merger Discussions Begin for Quantel Medical and Ellex

Quantel Medical, a division of Lumibird Group, recently announced that merger discussions have commenced with Ellex. Both ophthalmic medical device companies share the same goal – fighting the major causes of blindness – as well as the same purpose, values and established reputation.

Quantel Medical CEO Jean-Marc Gendre said that “the future success of the both companies depend on the sharing of R&D capabilities and manufacturing structures, and on strengthening our approach to clinical research in order to meet the current and future needs of ophthalmologists”. The French company has a strong emphasis in R&D and a comprehensive portfolio of diagnostic ultrasound, surgical lasers and a range of disposable products for ophthalmologists.

Meanwhile, Australia-based Ellex designs, manufactures and sells ophthalmic lasers and devices to treat glaucoma and retinal disease (primarily caused by diabetes, secondary cataract and vitreous opacities), as well as age-related macular degeneration.

Together, the complementary strengths of both companies – like strongly branded products and ophthalmic market knowhow – enables them to offer a broader range of products, at all price points, to better meet diverse client needs.

“We can offer clients a more holistic solution,” said Ellex Interim CEO Maria Maieli, adding that Ellex is particularly strong in laser treatment for glaucoma therapy, while Quantel Medical has a greater influence in laser treatment in retinal disease and diagnosis solutions.

In addition, the strength of Ellex’s market locations is matched and supported by Quantel Medical’s successful distribution channels. The merger will allow both companies to combine their market presence to satisfy existing customer requirements while exploring new markets – making the most of their respective strengths.

“The vision is to become the world leader in ophthalmic ultrasound and laser technology, to diagnosis and treat eye disease,” concluded Marc Le Flohic, CEO for Lumibird Group, one of the world’s leading laser specialists.