AGN-151597 (Formerly RST-001) Phase I/II Trial for Advanced Retinitis Pigmentosa

Study Identifier
RST-001-CP-0001
CT.gov Identifier
NCT02556736
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Plain Language Summary
Available Language(s): English
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Study Details

Medical Condition
  • Eye Disease
    • Study Drug
  • AGN-151597
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Participants must meet all of the following criteria. 1. Age \>= 18 years. 2. Signed and dated written informed consent obtained from the patient. 3. Ability to comply with testing and all protocol tests.
    Exclusion Criteria:
    Any one of the following will exclude patients from being enrolled into the study: 1. Unable or unwilling to meet requirements of the study. 2. Participation in a clinical study (ocular or non-ocular) with an investigational drug, agent or therapy in the past six months.

    Protocol Summary

    All participants in phase 1 and phase 2a had hand motion visual acuity or worse.

    If efficacy was demonstrated from phase 1, better vision subjects could be enrolled; however, efficacy was not demonstrated.

    Study Locations

    Location
    Status
    Location
    University of California San Francisco - Mission Bay /ID# 235717
    San Francisco, California, United States, 94158
    Status
    Not applicable
    Location
    Cincinnati Eye Institute- Edgewood /ID# 236713
    Edgewood, Kentucky, United States, 41017-3415
    Status
    Not applicable
    Location
    Duke Eye Center /ID# 235715
    Durham, North Carolina, United States, 27705
    Status
    Not applicable
    Location
    Retina Foundation of the Southwest /ID# 235199
    Dallas, Texas, United States, 75231
    Status
    Not applicable