Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases

A Phase 1 Safety And Effectiveness Study of Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases

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.

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Device: SeeQ CdSe 655 ALT

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Asociacion Para Evitar La Ceguera En Mexico, I.A.P. (APEC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects, 21 years of age or older.
2. Subjects with a history of degenerative retinal diseases such as RP.
3. Subjects with a documented history of disease progression.
4. Willing and able to return for all study visits.
5. Willing and able to provide written informed consent for the Clinical Study.
6. 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.
7. 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.
8. 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:

1. Subjects with significant lens or corneal pathology (either history of or current) in the study eye other than retinal diseases.
2. 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.)
3. Subjects whose retinal disease status has been stable for more than 90 days.
4. Subjects with history of iritis or uveitis in either eye.
5. Subjects who have monocular vision.
6. Subjects with a history of retinal detachment or tear in either eye.
7. 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.
8. Subjects with an aphakic study ete or if pseudophakic, cataract extraction surgery more than 6 months prior to study enrollment.
9. Subjects with a history of ocular trauma of any type in the study eye.
10. Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye, per the investigator's judgement.
11. Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy in the study eye).
12. Subjects with a history of cataract surgery complication in the study eye.
13. Subjects that have undergone previous photocoagulation of the retina in the study eye.
14. Subjects anticipated requiring cataract extraction in the study eye within the next six (6) months.
15. Subjects with congenital eye malformations.
16. Recurrent uveitis or history of uveitis in either eye.
17. Macular edema or history of macular edema in the study eye where central macular thickness is greater than 275 microns by OCT at baseline.
18. Ongoing ocular infection or inflammation in the study eye.
19. Pregnant or nursing females.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Severe Disease; Subjects with baseline BCVA between 20/16000 and hand motion (HM). Subjects received 2.0 μM concentration intravitreal injections on each Day 0 and Day 21.	Device: SeeQ CdSe 655 ALT; SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.
Experimental: Moderate to Severe Disease; Subjects with baseline BCVA from 20/60 to 20/16000. The first five (5) to receive 2.0 μM concentration intravitreal at each Day 0 and Day 21, the subsequent five (5) to receive 0.2 μM intravitreal injection at each Day 0 and Day 21, additional subjects (up to ten [10]) to receive one of the dosing options (either 2.0 μM or 0.2 μM) at each Day 0 and Day 21, at the discretion of the Investigator and Sponsor.	Device: SeeQ CdSe 655 ALT; SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Best Corrected Visual Acuity "BCVA"		Measured at Baseline through Day 42
Change in Contrast Sensitivity	Contrast sensitivity was measured utilizing a sin wave (Vistech) contrast sensitivity chart under photopic conditions	Measured at Baseline through Day 42
Change in ERG Amplitude	ERG amplitude was measured using Poland Consult ERG equipment	Measured at Baseline through Day 42
Change in Visual Fields	Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer	Measured at Baseline through Day 42
Change in Functional Vision	Functional Vision is tested using Object identification and White line orientation testing	Measured at Baseline through Day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of Effect	Measured at Baseline through Day 42

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Ocular Adverse Events	Safety Endpoint	Measured at Baseline through Day 42

Collaborators and Investigators

• Sponsor: 2C Tech Corp

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2014
• Primary Completion (Actual): December 19, 2014
• Study Completion (Actual): December 19, 2014

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Diseases; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: SeeQ 101.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No