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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: Completed Phase 1 study of LCA (Leber Congenital Amaurosis) and RP (Retinitis Pigmentosa), sponsored by QLT.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01014052 record still lists
NCT01014052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
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 lists 7 locations in 5 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01014052's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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