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Lack of funding.
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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2C-QD | Experimental | Single-dose intravitreal injection |
|
| Sham 2C-QD | Sham Comparator | Single-dose intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2C-QD | Device | Quantum Dot |
| |
| Sham 2C-QD |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular navigation performance | measured based on the ability to navigate the course under different light levels (defined as luminance) using the mobility course. | baseline to week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular navigation performance | measured using luminance level to complete the mobility course | baseline to week 4, 12, 24, 52 |
| binocular navigation performance | measured using luminance level to complete the mobility course |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Jackson, Professor | Kings College Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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Participants will be masked to the assignment of which eye is receiving active treatment or sham treatment. Clinical personnel who perform clinical assessments will also be masked to the participants' eye assignment. Masked evaluators will not be permitted in the room during the injections and will be instructed to avoid areas where they may observe study activities which may potentially lead to their becoming unmasked.
| Device |
Sham Intravitreal Injection |
|
| baseline to week 2, 4, 12, 24, 52 |
| monocular retinal sensitivity | measured using Octopus full-field static perimetry | baseline to week 2, 4, 12, 24, 52 |
| monocular best-corrected visual acuity (BCVA) | change in BCVA | baseline to week 2, 4, 12, 24, 52 |
| ellipsoid zone area | measured using spectral domain (SD) optical coherence tomography (OCT) | baseline to week 2, 4, 12, 24, 52 |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |