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NCT01014052 · ClinicalTrials.gov registry record · Phase 1
Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations
A Phase 1 study of LCA (Leber Congenital Amaurosis) and RP (Retinitis Pigmentosa), sponsored by QLT.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 7
- Study locations
NCT01014052 is a Phase 1 study of LCA (Leber Congenital Amaurosis) and RP (Retinitis Pigmentosa) that has completed, run by QLT. The registered enrollment target is 32 participants. The trial reports 7 study locations across 5 states.
The verdict
NCT01014052, a Phase 1 study of LCA (Leber Congenital Amaurosis) and RP (Retinitis Pigmentosa), has completed, sponsored by QLT.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is: * to evaluate the safety of oral QLT091001 * to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations * to evaluate duration of visual function improvement (if observed)
Conditions Studied
Interventions
- DRUG QLT091001
Study Locations (7)
Other
- Institute for Ophthalmic Research, University of Tubingen - Tübingen
- The Rotterdam Eye Hospital - Rotterdam
- Moorefield Eye Hospital - London
Illinois
- The Chicago Lighthouse for People Who Are Blind or Visually Impaired (The Pangere Center For Inherited Retinal Diseases) - Chicago
Maryland
- Wilmer Eye Institute (Johns Hopkins University) - Baltimore
Pennsylvania
- Scheie Eye Institute - Philadelphia
Quebec
- Montreal Children's Hospital, McGill University Health Centre - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01014052
The ClinicalTrials.gov registry entry for NCT01014052 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is QLT, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with LCA (Leber Congenital Amaurosis) appearing as the primary indexed condition, and to 1 intervention - of which QLT091001 is the first listed.
NCT01014052 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Other, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT01014052 about?
NCT01014052 is a clinical study titled "Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations". The purpose of this study is: * to evaluate the safety of oral QLT091001 * to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations * to evaluate duration of visual function improvement (if observed)
What is the current status of trial NCT01014052?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2009-11. Estimated completion is 2012-08.
What conditions does trial NCT01014052 study?
This clinical trial studies the following conditions: LCA (Leber Congenital Amaurosis), RP (Retinitis Pigmentosa).
What interventions are being tested in trial NCT01014052?
The interventions under investigation include: QLT091001 (DRUG).
Who is sponsoring clinical trial NCT01014052?
This trial is sponsored by QLT, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01014052 being conducted?
This trial has 7 study locations across Illinois, Maryland, Pennsylvania, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.