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

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
SeeQ CdSe 655 ALT
Sponsored by
2C Tech Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Retinitis Pigmentosa

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Severe Disease

Moderate to Severe Disease

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Effect

Full Information

First Posted
June 25, 2019
Last Updated
July 3, 2019
Sponsor
2C Tech Corp
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1. Study Identification

Unique Protocol Identification Number
NCT04008771
Brief Title
Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
Official Title
A Phase 1 Safety And Effectiveness Study of Intravitreal Injection of SeeQ CdSe 655 Alt Nanoparticles for Patients With Degenerative Retinal Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 6, 2014 (Actual)
Primary Completion Date
December 19, 2014 (Actual)
Study Completion Date
December 19, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
2C Tech Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study was a prospective, open label feasibility study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Severe Disease
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate to Severe Disease
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SeeQ CdSe 655 ALT
Intervention Description
SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.
Primary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity "BCVA"
Time Frame
Measured at Baseline through Day 42
Title
Change in Contrast Sensitivity
Description
Contrast sensitivity was measured utilizing a sin wave (Vistech) contrast sensitivity chart under photopic conditions
Time Frame
Measured at Baseline through Day 42
Title
Change in ERG Amplitude
Description
ERG amplitude was measured using Poland Consult ERG equipment
Time Frame
Measured at Baseline through Day 42
Title
Change in Visual Fields
Description
Visual Field improvement is assessed using a Humphrey/Zeiss Visual Field Analyzer
Time Frame
Measured at Baseline through Day 42
Title
Change in Functional Vision
Description
Functional Vision is tested using Object identification and White line orientation testing
Time Frame
Measured at Baseline through Day 42
Secondary Outcome Measure Information:
Title
Duration of Effect
Time Frame
Measured at Baseline through Day 42
Other Pre-specified Outcome Measures:
Title
Rate of Ocular Adverse Events
Description
Safety Endpoint
Time Frame
Measured at Baseline through Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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. 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.
Facility Information:
Facility Name
Asociacion Para Evitar La Ceguera En Mexico, I.A.P. (APEC)
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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