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

Study acronym: ILLUMINATE
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint revisedv30 Show 6 more changesShow less
    • Study sites: 20 to 14
    • Primary completion date changed from estimate of Dec 2021 to Jan 31, 2022
    • Study completion date: Dec 2021 to Mar 2023
    • Eligibility criteria expanded, about 269 words
    • Secondary endpoints: 19 to 16
    • Study description expanded, about 8 words
  2. Primary completion date: Dec 2020 to Dec 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 36
    • Site details revised at 20 of 20 sites
    v29
  3. Site details revised at 1 of 20 sitesv28
  4. Site details revised at 1 of 20 sitesv27
  5. Site details revised at 1 of 20 sitesv26
Show 24 earlier versionsHide 24 earlier versions
  1. Site details revised at 4 of 20 sitesv25
  2. Site contacts updated at 1 of 20 sitesv24
  3. Study sites: 17 to 20v23
  4. Site details revised at 2 of 17 sitesv22
  5. Site details revised at 1 of 17 sitesv21
  6. Site contacts updated at 2 of 17 sitesv20
  7. Site contacts updated at 1 of 17 sitesv19
  8. Site contacts updated at 1 of 17 sitesv18
  9. Site contacts updated at 1 of 17 sitesv17
  10. Site details revised at 5 of 17 sitesv16
  11. Study title expanded, about 5 wordsv15
  12. Eligibility criteria shortened, about 13 words
    • Site details revised at 2 of 17 sites
    v14
  13. Study title expanded, about 1 wordv13
  14. Interventions: QR-110 (Drug), Sham (Other) to Sham (Other), sepofarsen (Drug)
    • Site contacts updated at 1 of 17 sites
    • Study description expanded, about 2 words
    • Study title expanded, about 1 word
    v12
  15. Site contacts updated at 2 of 17 sitesv11
  16. Site details revised at 1 of 17 sitesv10
  17. Site details revised at 3 of 17 sitesv9
  18. Site contacts updated at 5 of 17 sitesv8
  19. Re-verified, no change to tracked fieldsv7
  20. Site details revised at 9 of 17 sitesv6
  21. Study sites: 16 to 17v5
  22. Study sites: 6 to 16v4
  23. Site details revised at 1 of 6 sitesv3
  24. Study sites: 1 to 6v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT03913143
Lead Sponsor ProQR Therapeutics
Conditions
(from sponsor)		 Leber Congenital Amaurosis 10, Blindness, Leber Congenital Amaurosis, Vision Disorders, Sensation Disorders, Neurologic Manifestations, Eye Diseases, Eye Diseases, Hereditary +2 more
Related terms Blindness, Eye Abnormalities, Eye Diseases, Eye Diseases, Hereditary, Leber Congenital Amaurosis, Leber Congenital Amaurosis 10, Meckel Syndrome, Type 4, Neurologic Manifestations, Optic Atrophy, Hereditary, Leber, Retinal Diseases, Sensation Disorders, Vision Disorders
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov