Trial · NCT03913130
Extension Study to Study PQ-110-001 (NCT03140969)
NCT03913130, Phase 1, Phase 2, Terminated, Laboratoires Thea; results first posted 2023-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study to Study PQ-110-001 (NCT03140969). Trials, record NCT03913130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03913130
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study to Study PQ-110-001 (NCT03140969)
- NCT number
- NCT03913130
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Laboratoires Thea
- 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
- QR-110
- First posted
- 2019-04-12
- Last updated
- 2024-10-15
- Other registries' IDs
- eudract:2018-003500-40
- Results first posted
- 2023-01-04
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Ocular AEs | 24 months | Frequency of ocular adverse events (AEs) |
| Primary | Frequency of Non-ocular AEs | 24 months | Frequency of non-ocular AEs |
| Secondary | Change in BCVA in First Treated Eye | 24 months | Change in Best Corrected Visual Acuity (BCVA) in First Treated Eye |
| Secondary | Change in Mobility Course Score | 24 months | Change in Mobility course score |
| Secondary | Change in Photoreceptor Outer Segment Layer Thickness | 24 months | Change in photoreceptor outer segment layer thickness by Optical Coherence Tomography (OCT) |
| Secondary | Change in OCI | 24 months | Change in Oculomotor Instability (OCI) |
| Secondary | Change in FST Blue | 24 months | Change in Full-Field Stimulus Testing (FST) - blue stimuli |
| Secondary | Change in FST Red | 24 months | Change in Full-Field Stimulus Testing (FST) - red stimuli |
| Secondary | Change in VFQ-25 | 24 months | Change in Visual Function Questionnaire-25 (VFQ-25) score (adult subjects) |
| Secondary | Change in CVAQ | 24 months | Change in Cardiff Visual Ability Questionnaire for Children (CVAQC) score (pediatric subjects) |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Frequency of Ocular AEs | 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Frequency of Non-ocular AEs | 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in BCVA in First Treated Eye | 24 months | logMAR | MEAN | |
| SECONDARY | Change in Mobility Course Score | 24 months | |||
| SECONDARY | Change in Photoreceptor Outer Segment Layer Thickness | 24 months | |||
| SECONDARY | Change in OCI | 24 months | |||
| SECONDARY | Change in FST Blue | 24 months | |||
| SECONDARY | Change in FST Red | 24 months | |||
| SECONDARY | Change in VFQ-25 | 24 months | |||
| SECONDARY | Change in CVAQ | 24 months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Ocular AEs | Drug QR-110 | 7 | Participants | ||
| Frequency of Non-ocular AEs | Drug QR-110 | 6 | Participants | ||
| Change in BCVA in First Treated Eye | Drug QR-110 | 0.03 | Standard Deviation 0.17 | logMAR | |
| Change in BCVA in Treated Contralateral Eye | Drug QR-110 | -0.11 | Standard Deviation 0.23 | logMAR | |
| Change in BCVA in Non-Treated Contralateral Eye | Drug QR-110 | 0.05 | Standard Deviation 0.21 | logMAR |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Drug QR-110 | 9 | |
| Overall Study | COMPLETED | Drug QR-110 | 8 | |
| Overall Study | NOT COMPLETED | Drug QR-110 | 1 |
Source ClinicalTrials.gov
Adverse events34
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 | Cataract | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Cataract cortical | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Cataract subcapsular | Eye disorders | Drug QR-110 | 2 | 9 | |
| other | Conjunctival haemorrhage | Eye disorders | Drug QR-110 | 2 | 9 | |
| other | Cystoid macular oedema | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Dry eye | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Eye pain | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Eye pruritus | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Lacrimation increased | Eye disorders | Drug QR-110 | 1 | 9 | |
| other | Lenticular opacities | Eye disorders | Drug QR-110 | 2 | 9 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug QR-110 | 0 | 9 |
| Total, other adverse events | Drug QR-110 | 8 | 9 |
| Total, serious adverse events | Drug QR-110 | 1 | 9 |
Source ClinicalTrials.gov
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/NCT03913130
GET https://conductscience.org/api/trials/v1/NCT03913130/events?page=2