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Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (RP) (QUANTUM)

Primary Purpose

Retinitis Pigmentosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
2C-QD
Sham 2C-QD
Sponsored by
2C Tech Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

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

Inclusion Criteria: Male or female adults, aged 18 years or older on the day of screening Clinical diagnosis of bilateral RP, based on two or more of the following: clinical features, visual field testing, retinal imaging, electrophysiological measures, or genetic testing BCVA of 6/60 (logMAR 1.0) or worse in both eyes, with loss of vision due to RP in the opinion of the Investigator. Central visual field of less than 20 degrees in both eyes Be able to follow instructions and ambulate Be able to complete at least one mobility course at highest luminance level using each eye separately Be able and willing to provide written informed consent, attend all scheduled visits and comply with all study procedures For females capable of becoming pregnant, agree to have urine pregnancy testing (must be negative) and must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). Acceptable forms of birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Exclusion Criteria: Presence of severe systemic disease resulting in a life expectancy shorter than 1 year Presence of retinal or optic nerve disease other than RP in either eye including cystoid macular oedema (CMO), glaucoma or ocular hypertension (IOP≥ 25mmHg), diabetic retinopathy, retinal vein occlusion, and age-related macular degeneration. Be currently using any topical therapy for CMO (e.g., carbonic anhydrase inhibitors, corticosteroids, NSAIDs) in either eye. Have the presence of an ocular media opacity in either eye, which in the opinion of the Investigator, will preclude an accurate evaluation at any time during the study Have the presence of active ocular or systemic infection or inflammation, or any history of intraocular inflammation in either eye Have had a prior vitrectomy in either eye Have a history of amblyopia in either eye Have current or former high myopia (>6 dioptres) in either eye Have undergone ocular surgery within 6 months of the screening visit in either eye or have planned ocular surgery in either eye Have one eye that is ineligible, or have asymmetrical ocular disease defined as a greater than 15 letter difference between the eyes based on BCVA results. Have participated in any study involving an investigational drug or device within the past 30 days or have ongoing participation in a study with an investigational drug or device or have participated in a clinical trial of gene or cell therapy at any time Have any clinical evidence that the Investigator feels would place the subject at increased risk with the investigational product

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    2C-QD

    Sham 2C-QD

    Arm Description

    Single-dose intravitreal injection

    Single-dose intravitreal injection

    Outcomes

    Primary Outcome Measures

    Monocular navigation performance
    measured based on the ability to navigate the course under different light levels (defined as luminance) using the mobility course.

    Secondary Outcome Measures

    Monocular navigation performance
    measured using luminance level to complete the mobility course
    binocular navigation performance
    measured using luminance level to complete the mobility course
    monocular retinal sensitivity
    measured using Octopus full-field static perimetry
    monocular best-corrected visual acuity (BCVA)
    change in BCVA
    ellipsoid zone area
    measured using spectral domain (SD) optical coherence tomography (OCT)

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    May 3, 2023
    Sponsor
    2C Tech Corp
    Collaborators
    ORA, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05841862
    Brief Title
    Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (RP) (QUANTUM)
    Official Title
    Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (QUANTUM): a Pilot, Randomized, Double-masked, Sham-controlled, Clinical Device Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    2C Tech Corp
    Collaborators
    ORA, Inc.

    4. Oversight

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

    5. Study Description

    Brief Summary
    Pilot, randomized, observer and participant masked, sham and fellow eye controlled, interventional clinical device trail to evaluate the safety and effectiveness of the 2C-QD device to improve visual function in adults with advanced Retinitis Pigmentosa (RP).
    Detailed Description
    Subjects will be informed about the study and potential risks and benefits, and then will provide written informed consent prior to study procedures being performed. Subjects will be screened for eligibility against criteria set forth within the clinical protocol. If subjects are eligible, they will be randomized to receive an intravitreal injection of the 2C-QD device in one eye, and the fellow eye will receive a sham injection and serve as the control. Subjects will then be following for 180 days, through 9 visits.

    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
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Participants will be masked to the assignment of which eye is receiving active treatment or sham treatment. Clinical personnel who perform clinical assessments will also be masked to the participants' eye assignment. Masked evaluators will not be permitted in the room during the injections and will be instructed to avoid areas where they may observe study activities which may potentially lead to their becoming unmasked.
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    2C-QD
    Arm Type
    Experimental
    Arm Description
    Single-dose intravitreal injection
    Arm Title
    Sham 2C-QD
    Arm Type
    Sham Comparator
    Arm Description
    Single-dose intravitreal injection
    Intervention Type
    Device
    Intervention Name(s)
    2C-QD
    Intervention Description
    Quantum Dot
    Intervention Type
    Device
    Intervention Name(s)
    Sham 2C-QD
    Intervention Description
    Sham Intravitreal Injection
    Primary Outcome Measure Information:
    Title
    Monocular navigation performance
    Description
    measured based on the ability to navigate the course under different light levels (defined as luminance) using the mobility course.
    Time Frame
    baseline to week 2
    Secondary Outcome Measure Information:
    Title
    Monocular navigation performance
    Description
    measured using luminance level to complete the mobility course
    Time Frame
    baseline to week 4, 12, 24, 52
    Title
    binocular navigation performance
    Description
    measured using luminance level to complete the mobility course
    Time Frame
    baseline to week 2, 4, 12, 24, 52
    Title
    monocular retinal sensitivity
    Description
    measured using Octopus full-field static perimetry
    Time Frame
    baseline to week 2, 4, 12, 24, 52
    Title
    monocular best-corrected visual acuity (BCVA)
    Description
    change in BCVA
    Time Frame
    baseline to week 2, 4, 12, 24, 52
    Title
    ellipsoid zone area
    Description
    measured using spectral domain (SD) optical coherence tomography (OCT)
    Time Frame
    baseline to week 2, 4, 12, 24, 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female adults, aged 18 years or older on the day of screening Clinical diagnosis of bilateral RP, based on two or more of the following: clinical features, visual field testing, retinal imaging, electrophysiological measures, or genetic testing BCVA of 6/60 (logMAR 1.0) or worse in both eyes, with loss of vision due to RP in the opinion of the Investigator. Central visual field of less than 20 degrees in both eyes Be able to follow instructions and ambulate Be able to complete at least one mobility course at highest luminance level using each eye separately Be able and willing to provide written informed consent, attend all scheduled visits and comply with all study procedures For females capable of becoming pregnant, agree to have urine pregnancy testing (must be negative) and must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). Acceptable forms of birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Exclusion Criteria: Presence of severe systemic disease resulting in a life expectancy shorter than 1 year Presence of retinal or optic nerve disease other than RP in either eye including cystoid macular oedema (CMO), glaucoma or ocular hypertension (IOP≥ 25mmHg), diabetic retinopathy, retinal vein occlusion, and age-related macular degeneration. Be currently using any topical therapy for CMO (e.g., carbonic anhydrase inhibitors, corticosteroids, NSAIDs) in either eye. Have the presence of an ocular media opacity in either eye, which in the opinion of the Investigator, will preclude an accurate evaluation at any time during the study Have the presence of active ocular or systemic infection or inflammation, or any history of intraocular inflammation in either eye Have had a prior vitrectomy in either eye Have a history of amblyopia in either eye Have current or former high myopia (>6 dioptres) in either eye Have undergone ocular surgery within 6 months of the screening visit in either eye or have planned ocular surgery in either eye Have one eye that is ineligible, or have asymmetrical ocular disease defined as a greater than 15 letter difference between the eyes based on BCVA results. Have participated in any study involving an investigational drug or device within the past 30 days or have ongoing participation in a study with an investigational drug or device or have participated in a clinical trial of gene or cell therapy at any time Have any clinical evidence that the Investigator feels would place the subject at increased risk with the investigational product
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Astrid Berthe
    Phone
    (949) 461-1080
    Email
    aberthe@2ctechcorp.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy Jackson, Professor
    Organizational Affiliation
    Kings College Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (RP) (QUANTUM)

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