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Antisense Oligonucleotide

QR-421a for Retinitis Pigmentosa

Phase 2 & 3
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
Male or female, ≥ 18 years of age OR a minor (12 to < 18 years) with permission from a parent or legal guardian.
An adult willing to comply with the protocol, follow study instructions, attend study visits as required and willing and able to complete all study assessments. OR A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, and attend study visits with the subject as required.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 months
Awards & highlights

Study Summary

This trial is testing a new treatment for Retinitis Pigmentosa that involves injecting a medication into the eye. The study will evaluate how well the medication works and how safe it is.

Eligible Conditions
  • Retinitis Pigmentosa
  • Retinal Disease
  • Usher Syndrome
  • Deafblind
  • Eye Diseases
  • Congenital Eye Disorders
  • Vision Impairment

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Male or female, aged 12 or over OR a minor aged 12 to 17 with permission from a parent or legal guardian.
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A study participant who is an adult or a minor, is willing to comply with the study protocol, is able to complete all study assessments, and has a parent or caregiver who is willing and able to follow study instructions and attend study visits with the subject as required.
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The patient has good vision and their pupils are dilated enough to allow a good view of their retinas.
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No limitations to the amount or quality of data that can be collected using SD-OCT means that high quality, reliable images can be obtained from both eyes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 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
Change From Baseline in Mean Sensitivity
Secondary outcome measures
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Change From Baseline in Full-field Stimulus Threshold (FST)
Change From Baseline in Low Luminance Visual Acuity (LLVA)
+8 more
Other outcome measures
Change From Baseline in Mobility Course Score

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: QR-421a 60/60 µgExperimental Treatment1 Intervention
60 µg loading dose administered on Day 1, 60 µg maintenance dose administered at Month 3 and every 6 months thereafter
Group II: QR-421a 180/60 µgExperimental Treatment1 Intervention
180 µg loading dose administered on Day 1, 60 µg maintenance dose administered at Month 3 and every 6 months thereafter
Group III: Sham-procedurePlacebo Group1 Intervention
Sham-procedure (no experimental drug administered) on Day 1, Month 3 and every 6 months thereafter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QR-421a
2019
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

ProQR TherapeuticsLead Sponsor
11 Previous Clinical Trials
292 Total Patients Enrolled
4 Trials studying Retinitis Pigmentosa
133 Patients Enrolled for Retinitis Pigmentosa
ProQR Clinical Trial ManagerStudy DirectorProQR Therapeutics
3 Previous Clinical Trials
112 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
112 Patients Enrolled for Retinitis Pigmentosa
ProQR Medical MonitorStudy DirectorProQR Therapeutics
7 Previous Clinical Trials
172 Total Patients Enrolled
3 Trials studying Retinitis Pigmentosa
112 Patients Enrolled for Retinitis Pigmentosa

Frequently Asked Questions

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

Are we recruiting participants for this research at the moment?

"Unfortunately, this specific study is no longer looking for patients to enroll. The trial was initially posted on December 15th 2021 but the most recent update occurred on April 21st, 2022. However, there are 1258 other clinical trials that are still recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Puerto Rico
Texas
How old are they?
18 - 65
What site did they apply to?
Moorfields Eye Hospital
Retina Foundation of the Southwest
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
~2 spots leftby Jun 2025