The Ora-VNC™ Mobility Courses: Advancing IRD Research
Inherited Retinal Diseases (IRDs) are characterized by progressive vision loss due to genetic abnormalities that ultimately lead to blindness. In many instances, standard ophthalmic endpoints for assessing vision, such as reading an eye chart or performing a visual field, are not appropriate for patients with IRDs. The vision loss associated with IRDs can be so significant that patients are unable to read an eye chart at all, or effectively fixate to enable a visual field test. To address the need for functional endpoints in IRD patients, Ora has developed the Ora-VNC™ mobility courses which are designed to assess mobility and functional vision in patients with IRDs. The Ora-VNC™ courses can be used to objectively assess changes in patient mobility that are secondary to improvements in vision resulting from therapeutic intervention.
The Ora-VNC™ mobility courses are designed to detect differences in visual function impairment specific to IRDs such as Retinitis Pigmentosa, Achromatopsia, Choroideremia, Retinoschisis, Leber’s Hereditary Optic Neuropathy and Leber’s Congenital Amaurosis. The tests enable clinically meaningful assessments of visual function through immersion of patients in a 360-degree visual challenge environment. Mobility courses challenge specific aspects of vision that deteriorate with IRDs.
Different Ora-VNC™Mobility Courses for Different Diseases and Severities
No single obstacle course is appropriate for all IRDs, since the nature and severity of vision loss can be extremely variable and IRD-specific. Some IRDs are characterized by central vision loss (Leber’s Hereditary Optic Neuropathy), some by light perception loss (Leber’s Congenital Amaurosis), and others by peripheral vision loss (Retinitis Pigmentosa). Ora offers multiple Ora-VNC™ mobility courses to accommodate various types of vision loss as well as different severities, with certain courses that are appropriate for patients with vision levels ranging from mild restricted visual field (with preserved central acuity) to “light perception” only.
Inherited Retinal Diseases are rare, and as a result multiple clinical sites are typically required to enroll sufficient patient numbers for interventional trials. The multi-center nature of IRD studies complicates assessments of patient mobility, as mobility testing requires standardization of ambient lighting levels, obstacles, and administration procedures. Ora-VNC™ mobility courses are completely modular and are designed to enable efficient set-up in any clinical center, without changes to site infrastructure. Following course set-up and validation, robust training and certification of on-site technicians are performed. Mobility test sessions are recorded and sent to Ora’s independent reading center, where certified, masked graders score patient performance in an FDA compliant manner ensuring consistent and objective grading across all clinical sites.
Ora-VNC™ mobility courses provide standardization of ambient light levels independent of room size and features and employ multiple course iterations to prevent patient memorization. Ora’s mobility courses have also been presented to the Food and Drug Administration (FDA) as integral endpoints in gene therapy, oligonucleotides, RNA therapy and medical device development programs.
Key Features of the Ora-VNC™Mobility Course System:
- Able to assess the impact of therapies on IRDs (inherited retinal diseases)
- Sensitive to changes in visual function
- Provides clinically meaningful assessment of vision
- Designed for use in multi-center studies
- Customizable with an array of difficulty levels to cater to a variety of per protocol patient populations
- Easy to use and highly mobile
- Incorporates a robust training system and standard protocol for use
- Includes a fully masked and independent reading center grading system for objective scoring of mobility test performance