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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryFrequency of Ocular AEs24 monthsFrequency of ocular adverse events (AEs)
PrimaryFrequency of Non-ocular AEs24 monthsFrequency of non-ocular AEs
SecondaryChange in BCVA in First Treated Eye24 monthsChange in Best Corrected Visual Acuity (BCVA) in First Treated Eye
SecondaryChange in Mobility Course Score24 monthsChange in Mobility course score
SecondaryChange in Photoreceptor Outer Segment Layer Thickness24 monthsChange in photoreceptor outer segment layer thickness by Optical Coherence Tomography (OCT)
SecondaryChange in OCI24 monthsChange in Oculomotor Instability (OCI)
SecondaryChange in FST Blue24 monthsChange in Full-Field Stimulus Testing (FST) - blue stimuli
SecondaryChange in FST Red24 monthsChange in Full-Field Stimulus Testing (FST) - red stimuli
SecondaryChange in VFQ-2524 monthsChange in Visual Function Questionnaire-25 (VFQ-25) score (adult subjects)
SecondaryChange in CVAQ24 monthsChange in Cardiff Visual Ability Questionnaire for Children (CVAQC) score (pediatric subjects)

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYFrequency of Ocular AEs24 monthsParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYFrequency of Non-ocular AEs24 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange in BCVA in First Treated Eye24 monthslogMARMEAN
SECONDARYChange in Mobility Course Score24 months
SECONDARYChange in Photoreceptor Outer Segment Layer Thickness24 months
SECONDARYChange in OCI24 months
SECONDARYChange in FST Blue24 months
SECONDARYChange in FST Red24 months
SECONDARYChange in VFQ-2524 months
SECONDARYChange in CVAQ24 months

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Frequency of Ocular AEsDrug QR-1107Participants
Frequency of Non-ocular AEsDrug QR-1106Participants
Change in BCVA in First Treated EyeDrug QR-1100.03Standard Deviation 0.17logMAR
Change in BCVA in Treated Contralateral EyeDrug QR-110-0.11Standard Deviation 0.23logMAR
Change in BCVA in Non-Treated Contralateral EyeDrug QR-1100.05Standard Deviation 0.21logMAR

Participant flow3

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDDrug QR-1109
Overall StudyCOMPLETEDDrug QR-1108
Overall StudyNOT COMPLETEDDrug QR-1101

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCataractEye disordersDrug QR-11019
otherCataract corticalEye disordersDrug QR-11019
otherCataract subcapsularEye disordersDrug QR-11029
otherConjunctival haemorrhageEye disordersDrug QR-11029
otherCystoid macular oedemaEye disordersDrug QR-11019
otherDry eyeEye disordersDrug QR-11019
otherEye painEye disordersDrug QR-11019
otherEye pruritusEye disordersDrug QR-11019
otherLacrimation increasedEye disordersDrug QR-11019
otherLenticular opacitiesEye disordersDrug QR-11029

Adverse event totals3

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityDrug QR-11009
Total, other adverse eventsDrug QR-11089
Total, serious adverse eventsDrug QR-11019

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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