Trial · NCT05085964

An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa

NCT05085964, Phase 2, Terminated, Laboratoires Thea; results first posted 2022-12-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa. Trials, record NCT05085964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05085964

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa
NCT number: NCT05085964
Status: Terminated
Phases: Phase 2
Enrollment: 21 participants, actual
Lead sponsor: Laboratoires Thea
Conditions: Retinitis Pigmentosa, Usher Syndrome Type 2
Interventions: RNA antisense oligonucleotide for intravitreal injection
First posted: 2021-10-20
Last updated: 2024-08-07
Other registries' IDs: eudract:2021-002070-93
Results first posted: 2022-12-27
Limitations and caveats: Study prematurely terminated due to sponsor decision for reasons unrelated to safety.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Ocular Adverse Events (AEs)	1 year, 1 month	Number of subjects with ocular treatment emergent adverse events (TEAEs) in the contralateral eye (CE) is presented. Frequency of individual TEAEs by system organ class and preferred term is presented in the safety section and clinical trial summary report. Time frame of reporting is the maximum followup period from first subject first visit to last end of study visit.
Primary	Non-ocular Adverse Events (AEs)	1 year, 1 month	Number of subjects with non-ocular treatment emergent adverse events (TEAEs) is presented. Frequency of individual TEAEs by system organ class and preferred term is presented in the safety section and clinical trial summary report. Time frame of reporting is the maximum follow up period from first subject first visit to last end of study visit.
Secondary	Best Corrected Visual Acuity (BCVA)	24 months	Change from baseline
Secondary	Low Luminance Visual Acuity (LLVA)	24 months	Change from baseline
Secondary	Ellipsoid Zone (EZ) Area/Width by Spectral Domain Optical Coherence Tomography (SD-OCT)	24 months	Change from baseline
Secondary	Static Perimetry	24 months	Change from baseline
Secondary	Microperimetry	24 months	Change from baseline
Secondary	Exposure of QR-421a in Serum	12 months	Exposure of QR-421a in serum

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Ocular Adverse Events (AEs)	1 year, 1 month	All participants who were enrolled and received at least 1 dose of ultevursen.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Non-ocular Adverse Events (AEs)	1 year, 1 month	All participants who were enrolled and received at least 1 dose of ultevursen.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Best Corrected Visual Acuity (BCVA)	24 months
SECONDARY	Low Luminance Visual Acuity (LLVA)	24 months
SECONDARY	Ellipsoid Zone (EZ) Area/Width by Spectral Domain Optical Coherence Tomography (SD-OCT)	24 months
SECONDARY	Static Perimetry	24 months
SECONDARY	Microperimetry	24 months
SECONDARY	Exposure of QR-421a in Serum	12 months

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Category	Value	Units
Ocular Adverse Events (AEs)	Ultevursen 180ug/60ug	Contralateral Eye (CE) - TEAEs	11	Participants
Ocular Adverse Events (AEs)	Ultevursen 60ug/60ug	Contralateral Eye (CE) - TEAEs	0	Participants
Ocular Adverse Events (AEs)	Ultevursen 180ug/60ug	No TEAEs reported	10	Participants
Non-ocular Adverse Events (AEs)	Ultevursen 180ug/60ug		11	Participants
Non-ocular Adverse Events (AEs)	Ultevursen 60 ug/60 ug		0	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ultevursen 180ug/60ug (N=21)	21
Overall Study	STARTED	Ultevursen 60ug/60ug (N=0)	0
Overall Study	COMPLETED	Ultevursen 180ug/60ug (N=21)	0
Overall Study	COMPLETED	Ultevursen 60ug/60ug (N=0)	0
Overall Study	NOT COMPLETED	Ultevursen 180ug/60ug (N=21)	21
Overall Study	NOT COMPLETED	Ultevursen 60ug/60ug (N=0)	0

Source ClinicalTrials.gov

Adverse events10

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
other	Conjunctival haemorrhage	Eye disorders	Ultevursen 180ug/60ug	8	21
other	Conjunctival haemorrhage	Eye disorders	Ultevursen 60ug/60ug	0	0
other	Eye pain	Eye disorders	Ultevursen 180ug/60ug	7	21
other	Eye pain	Eye disorders	Ultevursen 60ug/60ug	0	0
other	Conjunctival hyperaemia	Eye disorders	Ultevursen 180ug/60ug	2	21
other	Conjunctival hyperaemia	Eye disorders	Ultevursen 60ug/60ug	0	0
other	COVID-19	Infections and infestations	Ultevursen 180ug/60ug	4	21
other	COVID-19	Infections and infestations	Ultevursen 60ug/60ug	0	0
other	Nasopharyngitis	Infections and infestations	Ultevursen 180ug/60ug	2	21
other	Nasopharyngitis	Infections and infestations	Ultevursen 60ug/60ug	0	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ultevursen 180ug/60ug	0	21
Total, all-cause mortality	Ultevursen 60ug/60ug	0	0
Total, other adverse events	Ultevursen 180ug/60ug	11	21
Total, other adverse events	Ultevursen 60ug/60ug	0	0
Total, serious adverse events	Ultevursen 180ug/60ug	0	21
Total, serious adverse events	Ultevursen 60ug/60ug	0	0

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.

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/NCT05085964

GET https://conductscience.org/api/trials/v1/NCT05085964/registered

API reference For AI assistants