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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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