Clinical trial study results for optomap^® suggest that peripheral retinal lesions predict progression of diabetic retinopathy

HIGHLIGHTS

• Prospective 4 year study shows significance of peripheral lesions in predicting 3 to nearly 5-fold increased risk of diabetic retinopathy progression and development of proliferative diabetic retinopathy, respectively.
• Study identifies a population of patients with retinal lesions predominantly outside the area imaged by standard retinal fundus photography that are at a substantially higher risk of diabetic retinopathy progression than might be suggested by findings on standard retinal photography alone.
• The presence of predominantly peripheral diabetic lesions substantially increases the risks of diabetic retinopathy progression and the onset of proliferative diabetic retinopathy, demonstrating the importance of rigorous evaluation of the peripheral retina to more accurately evaluate diabetic retinopathy severity and determine progression risk. 
• The presence and severity of diabetic retinopathy lesions predominantly located in the periphery are not currently evaluated in standard Early Treatment Diabetic Retinopathy Severity (ETDRS) severity grading that has been used in many clinical and research settings.  These results are currently under investigation in a multicentre study sponsored by the Diabetic Retinopathy Clinical Research Network to confirm the findings and see if changes to the current ETDRS grading scales are needed to best optimise the determination of diabetic retinopathy progression risk.  
• The presence of predominantly peripheral lesions was associated with the progression of diabetic retinopathy over 4 years, independent of baseline retinopathy severity and haemoglobin A1C. 

Dunfermline, Scotland 31 Aug 2015 – Optos, a wholly owned subsidiary of Nikon Corporation, Japan and world leader in retinal imaging, announced the publication of a study in the May 2015 issue of the journal Ophthalmology. The study was conducted by Dr. Paolo Silva (Staff Ophthalmologist and Assistant Chief of Telemedicine at Joslin’s Beetham Eye Institute; and Assistant Professor of Ophthalmology at Harvard Medical School) and Dr. Lloyd Paul Aiello, (Director of Joslin’s Beetham Eye Institute and Professor of Ophthalmology at Harvard Medical School).

The primary objective of the study was to investigate whether peripheral diabetic retinal lesions predicted an increased risk of diabetic retinopathy progression and onset of proliferative diabetic eye disease. Data from this study suggest that the rigorous evaluation of the peripheral retina may help more accurately assess risk of diabetic retinopathy severity progression.   

The 4 year clinical study of 100 patients was conducted independently by researchers at Joslin Diabetes Center, the Boston-based nonprofit institution providing premier diabetes care and innovative research for diabetes and its complications. The research found that eyes with diabetic lesions that were predominantly located in the peripheral retina had a 4.7-fold increased risk of progression to proliferative diabetic retinopathy and a 3.2-fold increased risk of 2 or more step progression in diabetic retinopathy severity.  The results were statistically significant and were independent of baseline retinopathy severity and prior haemoglobin A1C.

 

In a previous study by the same researchers, the use of stereoscopic optomap images evaluated in a rigorous and standardized manner had excellent agreement with current gold standard method of diabetic retinopathy assessment, stereoscopic ETDRS 7 field standard field 35-mm colour 30-degree fundus photographs.  Previously published analyses have reported that these lesions may suggest a more severe level of diabetic retinopathy in ~10% of eyes.  The initial observation was confirmed in subsequent analysis of images from 1,516 eyes obtained in an established diabetic retinopathy telemedicine program where a more severe diabetic retinopathy level was suggested in 9% of eyes based on peripheral lesions identified using optomap imaging. This newest study demonstrates that evaluating diabetic retinopathy with ultra-widefield imaging can provide important diabetic retinopathy disease information using a non-mydriatic, fast and effective 200 degree retinal imaging platform.

Researchers believe that this is the first comprehensive study to quantitate the increased risk associated with the presence of predominantly peripheral diabetic retinopathy lesions visualised on ultra-widefield imaging.  Dr. Aiello said “These data re-affirm the importance of evaluating the entire retina when managing diabetic retinopathy and demonstrate the increased risk of retinopathy progression that could be missed if the peripheral retina is not carefully examined.  If currently on-going large multicentre trials confirm these results, then the status of the peripheral retina may need to be included in diabetic retinopathy grading scales to optimally define the risks of retinopathy progression in an individual.”

Roy Davis, CEO of Optos, said “We are pleased with the exciting results from this study.  Optos has long believed that an image of the retina including the far periphery enables an eye care professional to see more pathology easier and to develop more effective treatment plans for maintaining their patients’ vision.  An optomap is the most complete single image of the retina currently available and this study demonstrates its use as an integral part of a detailed peripheral retinal evaluation. For these reasons, Optos continues to invest in research and development as well as clinical studies that support optomap as an important component of the standard of care for triage and treatment decisions in retinal vascular diseases.”

Disclosures: Optos did not fund the study referenced in this press release.  Optos has funded other Beetham Eye Institute research.  The study publication contains a full financial disclosure.   The Joslin press release regarding this study is available on the Joslin website. Joslin does not endorse any products.

 

 

 

About Optos

Optos plc has the vision to be The Retina Company and recognised as a leading provider of devices to eyecare professionals for improved patient care. Optos' core devices produce ultra-widefield (UWF™), high resolution digital images (optomap^®) of approximately 82% and 200^◦ of the retina, something no other device is capable of doing in any single image.  An optomap image provides a bigger picture and more clinical information which facilitates the early detection, management and effective treatment of disorders and diseases evidenced in the retina such as retinal detachments and tears, glaucoma, diabetic retinopathy and age-related macular degeneration.  Retinal imaging can also indicate evidence of non-eye or systemic diseases such as hypertension and certain cancers.

 

Optos has a range of retinal imaging devices that support different customer segments and patient needs such as wellness screening carried out by optometrists in primary care settings or more exacting imaging in secondary care practices that are clinically managing a patient base with advanced ocular disease.  Our most advanced imaging devices for disease management and treatment support ophthalmologists and retinal specialists in the medical care market.

 

The latest products, Daytona and California represents the newest generation of Optos ultra-widefield retinal imaging technology and have been converted to desktop models while still providing high resolution images. For both devices, the ergonomic body is designed to increase patient comfort, as well as make it easier to correctly position the eye for image capture.  All image modalities; colour, red-free and autofluorescence (AF) are included in both devices.  California features fluorescein angiography (FA) and our newest UWF imaging modality, indocyanine green angiography.  ICG is used for imaging the choroidal vasculature which is important for the diagnosis, management and treatment of certain conditions such as neovascular age-related macular degeneration (AMD) and disorders with choroidal neovascular membranes. 

 

Optos also offers optical coherence tomography ("OCT") devices.  OCT delivers an image that shows a three dimensional, cross-sectional view of the retina in the central area of the retina around the optic nerve and macula and is used to detect the presence of and understand the severity of disease, determine treatment approaches and monitor post-treatment effect.  Currently under product development is an ultra-widefield retinal imaging device combined with OCT.  This united device has the potential to offer ophthalmologists and optometrists the most powerful tools for disease diagnosis, monitoring and management.  Beyond ultra-widefield imaging and OCT, the company’s expanded product range now includes visual acuity, perimetry and treatment laser products.

 

Optos is committed to utilising the latest technology to manufacture new products and software that support optomap as a standard of care therefore helping eyecare professionals around the world save sight and lives.  Furthermore the company continues to strengthen its clinical evidence and expand its disease indications to demonstrate the importance of imaging the entire retina.

 

In May, 2015 Optos became a wholly-owned subsidiary of Nikon Corporation, Japan.

 

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For more information please visit our website www.optos.com.

 

 

 

Enquiries

 

Optos plc                                 Tel: 01383 843 300  Roy Davis, CEO Robert Kennedy, CFO

 

Note to Editors: Images available upon request

 

Information from IDF

According to the International Diabetes Federation there are 382 million people living with diabetes globally with 46% of people remain undiagnosed.  The US Centers for Disease Control adds that as many as 50 percent of patients with diabetic retinopathy are not obtaining eye exams or are diagnosed too late for treatment to be optimally effective.  Patients with proliferative retinopathy can reduce their risk of blindness by 95 percent with timely treatment and appropriate follow-up care. In diagnosing diabetic retinopathy, early detection and treatment are both key to preserving patients’ vision.  Traditional dilated retinal examinations for diabetic retinopathy may involve lengthy appointments with expert ophthalmologists and specially trained ophthalmic photographers taking many small field fundus photos.