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OpenTrials
Completed

NCT Number: NCT04008771

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Recurrent uveitis or history of uveitis in either eye.
  • Macular edema or history of macular edema in the study eye where central macular thickness is greater than 275 microns by OCT at baseline.
  • Ongoing ocular infection or inflammation in the study eye.
  • Pregnant or nursing females.

Treatment and study plan

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.

Primary outcomes

  1. Change in Best Corrected Visual Acuity "BCVA"

    Time frame: Measured at Baseline through Day 42

  2. 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

  3. Change in ERG Amplitude

    Time frame: Measured at Baseline through Day 42

    ERG amplitude was measured using Poland Consult ERG equipment

  4. Change in Visual Fields

    Time frame: Measured at Baseline through Day 42

    Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer

  5. Change in Functional Vision

    Time frame: Measured at Baseline through Day 42

    Functional Vision is tested using Object identification and White line orientation testing

Secondary outcomes

  1. Duration of Effect

    Time frame: Measured at Baseline through Day 42

Other outcomes

  1. Rate of Ocular Adverse Events

    Time frame: Measured at Baseline through Day 42

    Safety Endpoint

Sponsors and collaborators

Lead sponsor

2C Tech Corp

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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