Retinitis PigmentosaNCT05841862
Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (RP) (QUANTUM)
A study testing 2C-QD in people with Retinitis Pigmentosa, run by 2C Tech Corp.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- 2C-QD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (QUANTUM): a Pilot, Randomized, Double-masked, Sham-controlled, Clinical Device Trial
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).
Read the 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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- 2C-QD, Sham 2C-QD
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2C-QDDevice
Quantum Dot
Sham 2C-QDDevice
Sham Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| 2C-QD | Experimental | Single-dose intravitreal injection Receives: Device: 2C-QD |
| Sham 2C-QD | Sham comparator | Single-dose intravitreal injection Receives: Device: Sham 2C-QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular navigation performance
measured based on the ability to navigate the course under different light levels (defined as luminance) using the mobility course.
Measured: baseline to week 2
Secondary outcomes (5)
Monocular navigation performance
measured using luminance level to complete the mobility course
Measured: baseline to week 4, 12, 24, 52
binocular navigation performance
measured using luminance level to complete the mobility course
Measured: baseline to week 2, 4, 12, 24, 52
monocular retinal sensitivity
measured using Octopus full-field static perimetry
Measured: baseline to week 2, 4, 12, 24, 52
monocular best-corrected visual acuity (BCVA)
change in BCVA
Measured: baseline to week 2, 4, 12, 24, 52
ellipsoid zone area
measured using spectral domain (SD) optical coherence tomography (OCT)
Measured: baseline to week 2, 4, 12, 24, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start20 Mar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 2C Tech Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Timothy Jackson, Professor, Principal investigator, Kings College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841862
- Sponsor's protocol ID
- 2C Tech-002
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (QUANTUM): a Pilot, Randomized, Double-masked, Sham-controlled, Clinical Device Trial
- ClinicalTrials.gov ID
- NCT05841862
- Acronym / sponsor ID
- 2C Tech-002
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 2C Tech CorpIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2C-QD | Experimental | Device: 2C-QDSingle-dose intravitreal injection |
| Sham 2C-QD | Sham comparator | Device: Sham 2C-QDSingle-dose intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2C-QDQuantum Dot | Device | 2C-QD |
| Sham 2C-QDSham Intravitreal Injection | Device | Sham 2C-QD |
Primary outcome
Monocular navigation performance
Time frame: baseline to week 2
measured based on the ability to navigate the course under different light levels (defined as luminance) using the mobility course.
5 secondary outcomes
Monocular navigation performance
Time frame: baseline to week 4, 12, 24, 52
binocular navigation performance
Time frame: baseline to week 2, 4, 12, 24, 52
monocular retinal sensitivity
Time frame: baseline to week 2, 4, 12, 24, 52
monocular best-corrected visual acuity (BCVA)
Time frame: baseline to week 2, 4, 12, 24, 52
ellipsoid zone area
Time frame: baseline to week 2, 4, 12, 24, 52
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Jackson, Professor principal investigator
Kings College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 2C-QD in people with Retinitis Pigmentosa, run by 2C Tech Corp.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular navigation performance (time frame: baseline to week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.