Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT01014052 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01014052 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01014052?
The interventions under investigation include: QLT091001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01014052?
This trial is sponsored by QLT, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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