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NCT02553135 · ClinicalTrials.gov registry record · Phase 2
Choroideremia Gene Therapy Clinical Trial
A Phase 2 study of Choroideremia, sponsored by Byron Lam.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT02553135: Completed Phase 2 study of Choroideremia, sponsored by Byron Lam.
NCT02553135 is a Phase 2 study of Choroideremia that has completed, run by Byron Lam. The registered enrollment target is 6 participants, below the 3,134-participant average among 7 other Choroideremia trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02553135, a Phase 2 study of Choroideremia, has completed, sponsored by Byron Lam.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients will be required to attend a total of 11 study visits over a 24 month period with an additional 3 year follow-up.
Primary Outcome
Patients will have an assessment of visual acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) vision charts in both eyes. Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart
Conditions Studied
Interventions
- BIOLOGICAL Injection of AAV2-REP1 (10e11 vg)
Study Locations (1)
Florida
- Bascom Palmer Eye Institute, University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-02 |
| Phase | Phase 2 |
What the finished NCT02553135 record still lists
NCT02553135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 3,134-participant average among 7 other Choroideremia trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Choroideremia appearing as the primary indexed condition, and to 1 intervention - of which Injection of AAV2-REP1 (10e11 vg) is the first listed.
NCT02553135 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02553135 about?
NCT02553135 is a clinical study titled "Choroideremia Gene Therapy Clinical Trial". Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients will be required to attend a total of 11 study visits over a 24 month period with an additional 3 year follow-up.
What is the current status of trial NCT02553135?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2015-09. Estimated completion is 2018-02.
What conditions does trial NCT02553135 study?
This clinical trial studies the following conditions: Choroideremia.
What interventions are being tested in trial NCT02553135?
The interventions under investigation include: Injection of AAV2-REP1 (10e11 vg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02553135?
This trial is sponsored by Byron Lam, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02553135 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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