Trial · NCT03913143
A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)
NCT03913143, Phase 2, Phase 3, Active not recruiting, ProQR Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE). Trials, record NCT03913143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03913143
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy, Safety, Tolerability and Exposure After a Repeat-dose of Sepofarsen (QR-110) in LCA10 (ILLUMINATE)
- NCT number
- NCT03913143
- Status
- Active not recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- ProQR Therapeutics
- Conditions
Leber Congenital Amaurosis 10, Blindness, Leber Congenital Amaurosis, Vision Disorders, Sensation Disorders, Neurologic Manifestations, Eye Diseases, Eye Diseases, Hereditary, Eye Disorders Congenital, Retinal Disease
- Interventions
- sepofarsen, Sham
- First posted
- 2019-04-12
- Last updated
- 2022-03-17
- Other registries' IDs
- eudract:2018-003501-25
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in BCVA | 12 months | Change in Best-corrected visual acuity (BCVA) relative to baseline after 12 months of treatment versus sham-procedure |
| Secondary | Change from baseline in BCVA ≤ -0.3 LogMAR | 12 and 24 months | Change from baseline in BCVA in subjects with BCVA better than 1.7 Logarithm of the minimum angle of resolution (LogMAR) at baseline |
| Secondary | Clinical meaningful improvement in subjects with BCVA ≤ 1.7 LogMAR | 12 and 24 months | Change from baseline in BCVA by a clinically meaningful improvement in subjects with BCVA equal to or worse than 1.7 LogMAR at baseline. |
| Secondary | Change in BCVA based on FrACT | 12 and 24 months | Change from baseline in BCVA based on Freiburg visual acuity and contrast test (FrACT) |
| Secondary | Change in mobility course score | 12 and 24 months | Change from baseline in mobility course score |
| Secondary | Change in ellipsoid zone (EZ) width/area assessed by SD-OCT | 12 and 24 months | Change from baseline in ellipsoid zone (EZ) width/area assessed by SD-OCT |
| Secondary | Change in oculomotor instability (OCI) | 12 and 24 months | Change in oculomotor instability from baseline |
| Secondary | Change in FST light sensitivity | 12 and 24 months | Change from baseline in light sensitivity Full-field light sensitivity threshold (FST) testing (white, red, blue) |
| Secondary | Change in LLVA | 12 and 24 months | Change from baseline in low luminance visual acuity (LLVA) |
| Secondary | Change in patient reported visual function via VFQ-25 (adults) | 12 and 24 months | Change in patient reported visual function, as measured by the Visual Function Questionnaire-25 (VFQ-25) score for adult subjects relative to baseline |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03913143
GET https://conductscience.org/api/trials/v1/NCT03913143/registered