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

NCT04008771 | Completed

• 1 other identifier: SeeQ 101.A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Duration of Effect

  Measured at Baseline through Day 42

Other Outcomes (1)

• Rate of Ocular Adverse Events

  Measured at Baseline through Day 42

Study Arms (2)

Severe Disease

EXPERIMENTAL

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

Moderate to Severe Disease

EXPERIMENTAL

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

Interventions

SeeQ CdSe 655 ALT DEVICE

SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.

Moderate to Severe Disease; Severe Disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy in the study eye).
• Subjects with a history of cataract surgery complication in the study eye.
• Subjects that have undergone previous photocoagulation of the retina in the study eye.
• Subjects anticipated requiring cataract extraction in the study eye within the next six (6) months.
• Subjects with congenital eye malformations.

Sponsors & Collaborators

• 2C Tech Corp: lead

Study Sites (1)

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

Mexico City, Mexico

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study was a prospective, open label feasibility study

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 5, 2019
• Study Start: January 6, 2014
• Primary Completion: December 19, 2014
• Study Completion: December 19, 2014
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)