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Antisense Oligonucleotide

QR-110 for Congenital Eye Disorders (INSIGHT Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by ProQR Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

INSIGHT Trial Summary

This trial is testing a new drug to see if it is safe and effective. If the data from the first trial suggests the drug is effective, subjects will be able to enroll in an extension study to continue receiving the drug.

Eligible Conditions

Congenital Eye Disorders
Retinal Disease
Blindness
Neurologic Symptoms
Vision Impairment
Sensory Disorders
Eye Diseases
Leber Congenital Amaurosis

INSIGHT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of Non-ocular AEs

Frequency of Ocular AEs

Secondary outcome measures

Change in BCVA in First Treated Eye

Change in BCVA in Non-Treated Contralateral Eye

Change in BCVA in Treated Contralateral Eye

+9 more

Side effects data

From 2019 Phase 1 & 2 trial • 11 Patients • NCT03140969

67%

Conjunctival haemorrhage

50%

Cataract

17%

Lenticular opacities

17%

Cataract cortical

17%

Dry eye

17%

Cataract subcapsular

17%

Conjunctival hyperaemia

100%

80%

60%

40%

20%

Study treatment Arm

QR-110 Low Dose

QR-110 Mid Dose

INSIGHT Trial Design

1Treatment groups

Experimental Treatment

Group I: Drug QR-110Experimental Treatment1 Intervention

First treated eye: maintenance dose every 6 months, intravitreal administration Contralateral eye: loading dose followed by maintenance dose, every 6 months, intravitreal administration

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

QR-110

2017

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ProQR TherapeuticsLead Sponsor

11 Previous Clinical Trials

288 Total Patients Enrolled

ProQR Medical MonitorStudy DirectorProQR Therapeutics

7 Previous Clinical Trials

168 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes does this clinical research endeavor to attain?

"This clinical trial is set to run for two years and its primary objective is to assess the frequency of non-ocular adverse effects. Secondary aims include an assessment of change in best corrected visual acuity, Cardiff Visual Ability Questionnaire for Children score (for pediatric participants), and modification of mobility course score."

Answered by AI

How many participants has the clinical trial garnered thus far?

"Unfortunately, this trial is no longer recruiting. The clinical study was publicly posted on May 13th 2019 and last updated on February 8th 2022. However, 1193 trials are actively seeking people with retinal diseases while 3 additional studies for QR-110 remain open to enrollment."

Answered by AI

Are there any precedents of QR-110's efficacy being evaluated through clinical research?

"As of now, QR-110 is being studied in three distinct clinical trials. Two are currently in the advanced Phase 3 stage with 32 trial sites throughout Strasbourg and Iowa."

Answered by AI

Does this investigation explore fresh approaches to treatment?

"Currently, QR-110 is being tested in 3 concurrent clinical trials across 11 cities and 9 countries. This research initiative was first launched by ProQR Therapeutics back in 2019 with 36 patients taking part. Since then, one study has been concluded during the Phase 2 & 3 drug approval process."

Answered by AI

Is this experiment still recruiting participants?

"Unfortunately, this clinical trial is not currently searching for participants. The information on the website states that it was initially posted on May 13th 2019 and revised February 8th 2022. However, if you are looking for other opportunities to become involved in a medical study, there exists 1193 trials recruiting patients with retinal diseases as well as 3 studies enrolling those affected by QR-110."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension Study to Study PQ-110-001 (NCT03140969)

2019. "Extension Study to Study PQ-110-001 (NCT03140969)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03913130.