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 – 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. These courses also:
Gain exclusive access to retina patients at integrated practice-based research sites in the U.S. with Ora’s exclusive retina site and patient network designed to connect investigators, sponsors and patients. Learn more on our Patient and Site Solutions page.
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, we conduct robust training and certification of on-site technicians. 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 to ensure consistent and objective grading across all clinical sites.
Ora-VNC™ mobility courses provide standardized 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 FDA as integral endpoints in gene therapy, oligonucleotides, RNA therapy, and medical device development programs.