A Phase 1 Safety And Effectiveness Study of Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- 2C Tech Corp
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Best Corrected Visual Acuity "BCVA"
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study was a prospective, open label feasibility study conducted at a single clinical site (APEC, Mexico City) to evaluate the safety and preliminary effectiveness of the SeeQ device, with each patient's serving as his/her own contralateral control.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects, 21 years of age or older.
- •Subjects with a history of degenerative retinal diseases such as RP.
- •Subjects with a documented history of disease progression.
- •Willing and able to return for all study visits.
- •Willing and able to provide written informed consent for the Clinical Study.
- •Subjects with a BCVA greater or equal to 20/16000 must have consistent fixation demonstrated by indirect ophthalmoscopy with a small circle of light and by consistent location of remaining central visual field detected by VFA.
- •Study Arm A: The best corrected visual acuity must be between 20/16000 and HM as tested by ETDRS chart and ERG B wave amplitude.
- •Study Arm B: The best-corrected visual acuity must be between 20/60 and 20/16000 and visual field of central 15 degrees (III static 30-2 protocol, 31.5 ASB background) greater than 10 dB loss, as determined by a Humphrey Instruments, Inc. Visual Field Analyzer (VFA).
Exclusion Criteria
- •Subjects with significant lens or corneal pathology (either history of or current) in the study eye other than retinal diseases.
- •Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters.)
- •Subjects whose retinal disease status has been stable for more than 90 days.
- •Subjects with history of iritis or uveitis in either eye.
- •Subjects who have monocular vision.
- •Subjects with a history of retinal detachment or tear in either eye.
- •Subjets with unstable IOP (i.e. \> 30 mmHg in the past six months) or IOP of \> 24 mm Hg at enrollment while under medical control. Subjects may be on topical medications to control their IOP.
- •Subjects with an aphakic study ete or if pseudophakic, cataract extraction surgery more than 6 months prior to study enrollment.
- •Subjects with a history of ocular trauma of any type in the study eye.
- •Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye, per the investigator's judgement.
Outcomes
Primary Outcomes
Change in Best Corrected Visual Acuity "BCVA"
Time Frame: Measured at Baseline through Day 42
Change in ERG Amplitude
Time Frame: Measured at Baseline through Day 42
ERG amplitude was measured using Poland Consult ERG equipment
Change in Visual Fields
Time Frame: Measured at Baseline through Day 42
Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer
Change in Functional Vision
Time Frame: Measured at Baseline through Day 42
Functional Vision is tested using Object identification and White line orientation testing
Change in Contrast Sensitivity
Time Frame: Measured at Baseline through Day 42
Contrast sensitivity was measured utilizing a sin wave (Vistech) contrast sensitivity chart under photopic conditions
Secondary Outcomes
- Duration of Effect(Measured at Baseline through Day 42)