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Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (RP) (QUANTUM) | Clinical Trials | Clareo Health

WITHDRAWNNA

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

Intravitreal Quantum Dots (QD) for Advanced Retinitis Pigmentosa (QUANTUM): a Pilot, Randomized, Double-masked, Sham-controlled, Clinical Device Trial

NCT05841862•2C Tech Corp

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female adults, aged 18 years or older on the day of screening
•2. 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
•3. 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.
•4. Central visual field of less than 20 degrees in both eyes
•5. Be able to follow instructions and ambulate
•6. Be able to complete at least one mobility course at highest luminance level using each eye separately
•7. Be able and willing to provide written informed consent, attend all scheduled visits and comply with all study procedures
•8. 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

•1. Presence of severe systemic disease resulting in a life expectancy shorter than 1 year
•2. 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.
•3. Be currently using any topical therapy for CMO (e.g., carbonic anhydrase inhibitors, corticosteroids, NSAIDs) in either eye.
•4. 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
•5. Have the presence of active ocular or systemic infection or inflammation, or any history of intraocular inflammation in either eye
•6. Have had a prior vitrectomy in either eye
•7. Have a history of amblyopia in either eye
•8. Have current or former high myopia (\>6 dioptres) in either eye
•9. Have undergone ocular surgery within 6 months of the screening visit in either eye or have planned ocular surgery in either eye
•10. 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.
+2 more criteria

Key Dates

Start Date

March 20, 2024

Primary Completion Date

March 1, 2025

Completion Date

March 1, 2025

Last Updated

June 12, 2025

Conditions

Retinitis Pigmentosa

Interventions

2C-QD

DEVICE

Sham 2C-QD

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa

A Phase 2 Open-label Study to Evaluate the Safety of Laruparetigene Zovaparvovec Administered Bilaterally in Male Participants With X-Linked Retinitis Pigmentosa

Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital

A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

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A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa