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

NCT05841862 | Withdrawn

• 1 other identifier: 2C Tech-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• Monocular navigation performance

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

  baseline to week 2

Secondary Outcomes (5)

• Monocular navigation performance

  baseline to week 4, 12, 24, 52

• binocular navigation performance

  baseline to week 2, 4, 12, 24, 52

• monocular retinal sensitivity

  baseline to week 2, 4, 12, 24, 52

• monocular best-corrected visual acuity (BCVA)

  baseline to week 2, 4, 12, 24, 52

• ellipsoid zone area

  baseline to week 2, 4, 12, 24, 52

Study Arms (2)

2C-QD

EXPERIMENTAL

Single-dose intravitreal injection

Device: 2C-QD

Sham 2C-QD

SHAM COMPARATOR

Single-dose intravitreal injection

Device: Sham 2C-QD

Interventions

2C-QD DEVICE

Quantum Dot

2C-QD

Sham 2C-QD DEVICE

Sham Intravitreal Injection

Sham 2C-QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 2C Tech Corp: lead
• ORA, Inc.: collaborator

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Timothy Jackson, Professor

  Kings College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: March 20, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share