Trial · NCT03140969
Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene
NCT03140969, Phase 1, Phase 2, Completed, Laboratoires Thea; results first posted 2022-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene. Trials, record NCT03140969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03140969
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate QR-110 in Leber's Congenital Amaurosis (LCA) Due to the c.2991+1655A>G Mutation (p.Cys998X) in the CEP290 Gene
- NCT number
- NCT03140969
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Laboratoires Thea
- Conditions
- Leber's Congenital Amaurosis
- Interventions
- QR-110
- First posted
- 2017-05-04
- Last updated
- 2024-10-15
- Other registries' IDs
- eudract:2017-000813-22
- Results first posted
- 2022-12-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency and Severity of Ocular Adverse Events in the Treatment and Contralateral Eyes | 1 year | |
| Secondary | Frequency and Severity of Non-ocular Adverse Events | 1 year | |
| Secondary | Change in Best-corrected Visual Acuity (BCVA) | 1 year | |
| Secondary | Change in Full-field Stimulus Test (FST) | 1 year | Average Red Light Score |
| Secondary | Change in Full-field Stimulus Test (FST) | 1 year | Average Blue Light Score |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency and Severity of Ocular Adverse Events in the Treatment and Contralateral Eyes | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency and Severity of Non-ocular Adverse Events | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Best-corrected Visual Acuity (BCVA) | 1 year | logMAR | MEAN | |
| SECONDARY | Change in Full-field Stimulus Test (FST) | 1 year | log cd/m2 | MEAN | |
| SECONDARY | Change in Full-field Stimulus Test (FST) | 1 year | log cd/m2 | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency and Severity of Ocular Adverse Events in the Treatment and Contralateral Eyes | QR-110 Low Dose | 6 | Participants | ||
| Frequency and Severity of Ocular Adverse Events in the Treatment and Contralateral Eyes | QR-110 Mid Dose | 5 | Participants | ||
| Frequency and Severity of Non-ocular Adverse Events | QR-110 Low Dose | 6 | Participants | ||
| Frequency and Severity of Non-ocular Adverse Events | QR-110 Mid Dose | 5 | Participants | ||
| Change in Best-corrected Visual Acuity (BCVA) | QR-110 Low Dose | Baseline (Absolute Values) | 2.597 | Standard Deviation 1.2738 | logMAR |
| Change in Best-corrected Visual Acuity (BCVA) | QR-110 Mid Dose | Baseline (Absolute Values) | 2.990 | Standard Deviation 1.4153 | logMAR |
| Change in Best-corrected Visual Acuity (BCVA) | QR-110 Low Dose | Changes from Baseline - Visit 8 (M3) | -0.813 | Standard Deviation 1.0073 | logMAR |
| Change in Best-corrected Visual Acuity (BCVA) | QR-110 Mid Dose | Changes from Baseline - Visit 8 (M3) | -0.126 | Standard Deviation 0.2165 | logMAR |
| Change in Best-corrected Visual Acuity (BCVA) | QR-110 Low Dose | Changes from Baseline - Visit 13 (M6) | -0.903 | Standard Deviation 1.0189 | logMAR |
| Change in Best-corrected Visual Acuity (BCVA) | QR-110 Mid Dose | Changes from Baseline - Visit 13 (M6) | -0.122 | Standard Deviation 0.1801 | logMAR |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QR-110 Low Dose | 6 | |
| Overall Study | STARTED | QR-110 Mid Dose | 5 | |
| Overall Study | STARTED | QR-110 High Dose | 0 | |
| Overall Study | COMPLETED | QR-110 Low Dose | 6 | |
| Overall Study | COMPLETED | QR-110 Mid Dose | 5 | |
| Overall Study | COMPLETED | QR-110 High Dose | 0 | |
| Overall Study | NOT COMPLETED | QR-110 Low Dose | 0 | |
| Overall Study | NOT COMPLETED | QR-110 Mid Dose | 0 | |
| Overall Study | NOT COMPLETED | QR-110 High Dose | 0 |
Source ClinicalTrials.gov
Adverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival haemorrhage | Eye disorders | QR-110 Low Dose | 4 | 6 | |
| other | Conjunctival haemorrhage | Eye disorders | QR-110 Mid Dose | 4 | 5 | |
| other | Cataract | Eye disorders | QR-110 Low Dose | 3 | 6 | |
| other | Cataract | Eye disorders | QR-110 Mid Dose | 4 | 5 | |
| other | Lenticular opacities | Eye disorders | QR-110 Low Dose | 1 | 6 | |
| other | Lenticular opacities | Eye disorders | QR-110 Mid Dose | 3 | 5 | |
| other | Conjunctival hyperaemia | Eye disorders | QR-110 Low Dose | 1 | 6 | |
| other | Conjunctival hyperaemia | Eye disorders | QR-110 Mid Dose | 2 | 5 | |
| other | Retinal degeneration | Eye disorders | QR-110 Low Dose | 0 | 6 | |
| other | Retinal degeneration | Eye disorders | QR-110 Mid Dose | 2 | 5 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QR-110 Low Dose | 0 | 6 |
| Total, all-cause mortality | QR-110 Mid Dose | 0 | 5 |
| Total, other adverse events | QR-110 Low Dose | 6 | 6 |
| Total, other adverse events | QR-110 Mid Dose | 5 | 5 |
| Total, serious adverse events | QR-110 Low Dose | 2 | 6 |
| Total, serious adverse events | QR-110 Mid Dose | 4 | 5 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| QR-110 Low Dose vs QR-110 Mid Dose: Frequency and Severity of Non-ocular Adverse Events | Trial comparisons |
| QR-110 Low Dose vs QR-110 Mid Dose: Frequency and Severity of Ocular Adverse Events in the Treatment and Contralateral Eyes | Trial comparisons |
| QR-110 Low Dose vs QR-110 Mid Dose: deaths from any cause | Trial comparisons |
| QR-110 Low Dose vs QR-110 Mid Dose: serious adverse events | Trial comparisons |
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/NCT03140969
GET https://conductscience.org/api/trials/v1/NCT03140969/events?page=2