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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
NCT02556736 |
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Date of registration:
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21/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa
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Scientific title:
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Phase I/IIa, Open-Label, Dose-Escalation Study of Safety and Tolerability of Intravitreal RST-001 in Patients With Advanced Retinitis Pigmentosa (RP) |
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Date of first enrolment:
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December 14, 2015 |
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Target sample size:
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14 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02556736 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Hanh Badger, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Advanced Retinitis Pigmentosa
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Intervention(s)
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Drug: RST-001
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Primary Outcome(s)
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Number of Participants With Any Grade 3 or Greater Adverse Event (AE) Considered Related to RST-001.
[Time Frame: Baseline (Day 1) to 6 Months]
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Secondary Outcome(s)
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Change in Quality of Life
[Time Frame: Baseline to 24 months]
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Change in Ambulation
[Time Frame: Baseline to 24 months]
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Visual Acuity
[Time Frame: Baseline to 24 months]
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Secondary ID(s)
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RST-001-CP-0001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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