Pilot, randomized, observer and participant masked, sham and fellow eye controlled, interventional clinical device trail to evaluate the safety and effectiveness of the 2C-QD device to improve visual function in adults with advanced Retinitis Pigmentosa (RP).
Subjects will be informed about the study and potential risks and benefits, and then will provide written informed consent prior to study procedures being performed. Subjects will be screened for eligibility against criteria set forth within the clinical protocol. If subjects are eligible, they will be randomized to receive an intravitreal injection of the 2C-QD device in one eye, and the fellow eye will receive a sham injection and serve as the control. Subjects will then be following for 180 days, through 9 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Quantum Dot
Sham Intravitreal Injection
Monocular navigation performance
measured based on the ability to navigate the course under different light levels (defined as luminance) using the mobility course.
Time frame: baseline to week 2
Monocular navigation performance
measured using luminance level to complete the mobility course
Time frame: baseline to week 4, 12, 24, 52
binocular navigation performance
measured using luminance level to complete the mobility course
Time frame: baseline to week 2, 4, 12, 24, 52
monocular retinal sensitivity
measured using Octopus full-field static perimetry
Time frame: baseline to week 2, 4, 12, 24, 52
monocular best-corrected visual acuity (BCVA)
change in BCVA
Time frame: baseline to week 2, 4, 12, 24, 52
ellipsoid zone area
measured using spectral domain (SD) optical coherence tomography (OCT)
Time frame: baseline to week 2, 4, 12, 24, 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.