Open-label, Multiple Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Efficacy of EA-2353 in Subjects With Retinitis Pigmentosa

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    14
  • sponsor
    Endogena Therapeutics, Inc
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Updated on 28 October 2022
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pupil dilation

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.

Description

This is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of EA-2353 in subjects with RP. There will be up to 4 cohorts. Each of the first three cohorts will treat 3 subjects with 4 weekly injections of EA-2353.

Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye, which is determined as the eye with worse vision based on the BCVA. Eligible subjects will be enrolled into one of the following three cohorts in an ascending sequential fashion:

  • Cohort 1 (low dose)
  • Cohort 2 (mid dose)
  • Cohort 3 (high dose)
  • Cohort 4 (maximum tolerated dose)

Patient participation will last for approximately 7 months.

Details
Condition Retinitis Pigmentosa, Retinitis Pigmentosa Syndrome
Treatment EA-2353
Clinical Study IdentifierNCT05392751
SponsorEndogena Therapeutics, Inc
Last Modified on28 October 2022

Eligibility

 Yes No Not Sure

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
Have a central retinal thickness (center point) >100 microns on SD-OCT

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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