WithdrawnNot Applicable

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

Stopped: Lack of funding.

0Started 2024-03-20

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Monocular navigation performance

Timeframe: baseline to week 2

Trial details

NCT IDNCT05841862

Sponsor2C Tech Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03

View on ClinicalTrials.gov More Retinitis Pigmentosa trials