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NCT03913143 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)

A Phase 2 study of Eye Diseases and Retinal Disease, sponsored by ProQR Therapeutics.

Active
Registry status
Phase 2
Development phase
36
Enrollment target
14
Study locations

NCT03913143 is a Phase 2 study of Eye Diseases and Retinal Disease that is active but no longer recruiting, run by ProQR Therapeutics. The registered enrollment target is 36 participants, below the 741,301-participant average among 27 other Eye Diseases trials with a reported enrollment target (100% lower). The trial reports 14 study locations across 6 states.

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The verdict

NCT03913143, a Phase 2 study of Eye Diseases and Retinal Disease, is active but no longer recruiting, sponsored by ProQR Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
36 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutation after 24 months of treatment

Conditions Studied

Eye Diseases Retinal Disease Eye Diseases, Hereditary Blindness Neurologic Manifestations Sensation Disorders Leber Congenital Amaurosis Vision Disorders Eye Disorders Congenital Leber Congenital Amaurosis 10

Interventions

  • DRUG sepofarsen
  • OTHER Sham

Study Locations (14)

Other

  • Universitair Ziekenhuis Gent (UZ) - Ghent
  • Centre de maladies rares CHNO des Quinze Vingt - Paris
  • Hospital Civil de Strasbourg - Strasbourg
  • Justus-Liebig Universität - Department of Ophthalmology - Giessen
  • University of Tuebingen - Inst. for Ophthalmic Research - Tübingen
  • Eye Clinic University of Campania Luigi Vanvitelli - Naples
  • Amsterdam University Medica Center - Locatie AMC - Amsterdam
  • Het Oogziekenhuis Rotterdam - Rotterdam
  • Moorfields Eye Hospital - NHS Foundation Trust - London

Iowa

  • University of Iowa - Iowa City

Minas Gerais

  • INRET Clínica/ Santa Casa de Misericórdia de Belo Horizonte - Belo Horizonte

São Paulo

  • Federal University of São Paulo - Hospital São Paulo (UNIFESP-HSP) - São Paulo

Ontario

  • The Hospital for Sick Children - SickKids - Toronto

Quebec

  • McGill University Health Centre - Centre for Innovative Medicine - Montreal

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2019-04-04
Est. Completion 2023-03
Phase Phase 2

Sponsor

ProQR Therapeutics

5 total trials

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What the Registry Record Tells You About NCT03913143

The ClinicalTrials.gov registry entry for NCT03913143 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 741,301-participant average among 27 other Eye Diseases trials with a reported enrollment target (100% lower). The listed sponsor is ProQR Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Eye Diseases appearing as the primary indexed condition, and to 2 interventions - of which sepofarsen is the first listed.

NCT03913143 reports 14 study locations spanning 6 distinct geographic areas - top geographies include Other, Iowa, Minas Gerais.

Frequently Asked Questions

What is clinical trial NCT03913143 about?

NCT03913143 is a clinical study titled "A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)". The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutati...

What is the current status of trial NCT03913143?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2019-04-04. Estimated completion is 2023-03.

What conditions does trial NCT03913143 study?

This clinical trial studies the following conditions: Eye Diseases, Retinal Disease, Eye Diseases, Hereditary, Blindness, Neurologic Manifestations.

What interventions are being tested in trial NCT03913143?

The interventions under investigation include: sepofarsen (DRUG), Sham (OTHER).

Who is sponsoring clinical trial NCT03913143?

This trial is sponsored by ProQR Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03913143 being conducted?

This trial has 14 study locations across Iowa, Minas Gerais, São Paulo, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.