Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects Wit… (NCT05392751) | Clinical Trial Compass
TerminatedPhase 1/2
Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa
Stopped: Study terminated by the Sponsor. All study participants completed at least 12 months of safety follow-up instead of 24 mo. The reason for earlier termination was due to a corporate decision; not any safety concerns of EA-2353.
United States14 participantsStarted 2022-06-02
Plain-language summary
This is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of EA-2353 in subjects with RP. Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye. There will be up to 4 cohorts.
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, ≥ 18 years of age.
. Have a clinical and molecular diagnosis of RP.
. Understand the language of the informed consent and are willing and able to provide written informed consent prior to any study procedures.
. Are willing to comply with the protocol and follow the instructions including attendance at all scheduled study visits.
. BCVA in the worse eye between 20/50 and able to count fingers (CF)
. Have clear ocular media.
. Have pupillary dilation sufficient to allow for quality images.
Exclusion criteria
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.
What they're measuring
1
Incidence and severity of adverse events
Timeframe: through study completion at 24 months
2
Incidence and severity of dose limiting toxicities (DLTs)
Timeframe: through study completion at 24 months
3
Establish the maximum tolerated dose (MTD) as determined by occurrence of DLTs
. Subjects who are pregnant or suspected to be pregnant and subjects who are lactating or intend to breastfeed. Female subjects of childbearing potential are required to have a negative urine pregnancy test at screening and prior to each injection, and must agree to use an acceptable method of contraception from the time of signing informed consent until the end of the study.
. Have any uncontrolled systemic disease or non-ocular disorder which would put the subject at risk due to study treatment or procedures, influence the results of the study, or impact the subject's ability to participate in the study (e.g., infection, uncontrolled elevated blood pressure, cardiovascular disease, and inability to maintain glycemic control).
. Presence of a significant ocular disease or disorder in the Study Eye.
. Have a history of any vitreoretinal surgery ever in the Study Eye.
. Have received any prior cell or gene therapy for RP.
. Have history or current abuse of alcohol and/or drugs.