Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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)

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

FieldValue
Enrollment Target 32 participants
Start Date 2009-11
Est. Completion 2012-08
Phase Phase 1

Sponsor

QLT

10 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.