Usher Syndrome, Type 2ACRUSHNCT04820244
Characterizing Rate of Progression in USHer Syndrome (CRUSH) Study
An observational study of Usher Syndrome, Type 2A and Retinitis Pigmentosa, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Mutations in USH2A give rise to two phenotypes: Usher syndrome type 2a (USH2A) and nonsyndromic RP (USH2A associated nsRP). Usher syndrome is the most common form of congenital deafblindness. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Usher Syndrome, Type 2A, Retinitis Pigmentosa, USH2A
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Feb 2019to 2 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The Dutch Usher syndrome population consists of an estimated 850 patients. Additionally we would like to include patients with USH2A associated nsRP. Subjects will be recruited from this population. In the past years it has been clear that patients are highly motivated to participate in research for their disease. We aim to include 50 subjects and given our past experiences, we consider this a feasible number of participants. The study population consists of both males and females between 16 and 55 years of age with a confirmed genetic diagnosis of USH2A associated RP either syndromic or nonsyndromic.
Who may be able to join
- Clinically diagnosed with rod-cone degeneration and at least two; pathogenic or likely pathogenic mutations in one of the Usher type 2 genes;
- Willing and able to complete the informed consent process;
- Ability to return for all study visits over 48 months;
- Age ≥ 16 years.
- Both eyes must meet all of the following:
- Clinical diagnosis of a rod-cone degeneration;
Show all 11Show fewer
- Clear ocular media and adequate pupil dilation to permit good quality photographic imaging;
- Ability to perform kinetic and static perimetry reliably;
- Baseline visual acuity ETDRS letter score of 54 or more [approximate Snellen equivalent 20/80 or better];
- Stable fixation;
- Clinically determined [on Octopus 900 Pro] kinetic visual field III4e area 7,5°, or more in the study eye.
Who cannot join
- Mutations in genes that cause autosomal dominant RP, X-linked RP, or presence of biallelic mutations in autosomal recessive RP/retinal dystrophy genes other than Usher genes;
- Expected to enter experimental treatment trial at any time during this study History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy (including hydroxychloroquine, chloroquine, thioridazine, and deferoxamine).
- If either eye has any of the following, the patient is not eligible:
- Current vitreous hemorrhage;
- Current or any history of rhegmatogenous retinal detachment;
- Current or any history of (e.g., prior to cataract or refractive surgery) spherical equivalent of the refractive error worse than -8 Diopters of myopia;
Show all 16Show fewer
- History of intraocular surgery (e.g., cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within the last 3 months;
- Current or any history of confirmed diagnosis of glaucoma (e.g., based on glaucoma visual field, nerve changes, or glaucoma filtering surgery);
- Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy;
- Expected to have cataract removal surgery during the study;
- History or current evidence of ocular disease that, in the opinion of the investigator, may confound assessment of visual function;
- History of treatment for retinitis pigmentosa that could affect the progression of retinal degeneration (including participation in a clinical trial within the last year or a retained drug delivery device).
- If either ear has any of the following, the patient is not eligible:
- The audiometric PTA(1-2-4kHz) for the best hearing ear should not exceed 75dB HL;
- Patients with bilateral cochlear implants cannot participate in the study;
- A planned, second, cochlear implantation during the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud universitair medisch centrum
Nijmegen, Gelderland, 6525 GA
About this study
Mutations in USH2A give rise to two phenotypes: Usher syndrome type 2a (USH2A) and nonsyndromic RP (USH2A associated nsRP). Usher syndrome is the most common form of congenital deafblindness. Patients with Usher syndrome are hearing impaired or profoundly deaf from birth and this can be rehabilitated with hearing aids or a cochlear implant. Furthermore, these patients develop retinitis pigmentosa (RP), a slowly progressive type of retinal degeneration that usually starts in the first or second decade of life. In both USH2A and nsRP patients the disease leads to severe visual impairment and eventually blindness around the 50th-70th year of life. There are no treatment options for the retinal degeneration. We do not know if they also suffer from balance complaints.
Currently, genetic therapy for Usher syndrome type 2 and USH2A associated nsRP is in development. But to measure the effect of a (genetic) therapy, it is crucial to know the detailed natural course of the visual and hearing deterioration over time. Several genetic therapy studies for other disorders are currently delayed, because the natural history of the disease has not been studied in detail previously.
Read more
The main objective is to map the natural course of the visual and hearing deterioration in Usher Syndrome 2 and USH2A associated nsRP for upcoming genetic therapy studies. Secondary objectives are: 1) To determine the necessary type of (combined) examinations, the sample size and length of studies (in years) essential to evaluate future genetic therapy in Usher syndrome. 2) To improve counselling of patients with Usher syndrome type 2 and USH2A associated nsRP with detailed information on the prognosis. 3) To identify additional etiological factors that explain variability in hearing impairment by adding questionnaires and psychophysical audiometric tests; and to assess the vestibular phenotype in Usher syndrome type 2 and USH2A associated nsRP patients.
This is a longitudinal, prospective natural history study. The study population consists of healthy human volunteers, 16 - 55 yr old with a confirmed genetic diagnosis of Usher Syndrome type 2 or and USH2A associated nsRP.
The main study endpoint is the natural course of the visual and hearing deterioration in Usher Syndrome type 2 and USH2A associated nsRP, over a time span of 4 years.
There are no risks associated with participation.
- Conditions
- Usher Syndrome, Type 2A, Retinitis Pigmentosa, USH2A
- Being tested
- No intervention
- Keywords
- USH2A, Non-Syndromal USH2 related Retinitis Pigmentosa, Natural history study
- Medical subject headings
- Usher syndrome, type 2A, Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Otherwise healthy human volunteers, 16-55 years old, with a confirmed genetic diagnosis of Usher Syndrome type 2 or non-syndromal USH2A related retinitis pigmentosa Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived visual functioning
Measured by the Visual Functioning Questionnaire-48 (VFQ-48): score of difficulty of performing 48 activities (items). The score is determined using two formulas: 'average item score = total item scores / (48 - U)' in which activities for which a person has non-visual reasons not to do it or in which they are not interested are scored with 'U', and '0.9*LN((2.34-average item score) / (average item score+2.22))+0.05'. The higher the score, the lower the perceived visual functioning.
Measured: Baseline, 2 years and study completion at 4 years
Change in perceived handicap due to hearing impairment
Measured by the Speech, Spatial and Qualities of Hearing Scale (SSQ): range 0-500, the higher the score, the fewer the perceived handicap due to hearing impairment.
Measured: Baseline, 2 years and study completion at 4 years
Change in perceived handicap due to dizziness
Measured by the Dizziness Handicap Inventory (DHI): range 0-100, the higher the score, the greater the perceived handicap due to dizziness.1. Pure tone audiometry and speech audiometry
Measured: Baseline, 2 years and study completion at 4 years
Change in lifestyle adjustment due to Usher syndrome.
Measured by the Usher lifestyle survey: qualitative questionnaire, no quantitative measures
Measured: Baseline, 2 years and study completion at 4 years
Change in perceived health
Measured by the 12-item Short-Form Health Survey (SF-12): 12 items with ranges 3-6, transformation of scores: ((patient score - lowest possible score)/range of scores)) * 100, the higher the score, the greater the perceived health.
Measured: Baseline, 2 years and study completion at 4 years
Change in the indication of depressive symptoms
Measured by the Patient Health Questionnaire Mood Scale (PHQ-9): range 0-27, the higher the score, the greater the indication of depressive symptoms.
Measured: Baseline, 2 years and study completion at 4 years
Change in overall condition of the eye
Measured by full ophthalmic exam.
Measured: Baseline and every year until study completion at 4 years
Change in visual acuity
Measured by best-corrected visual acuity.
Measured: Baseline and every year until study completion at 4 years
Change in visual fields area
Measured by dynamic perimetry with topographical analysis.
Measured: Baseline and study completion at 4 years
Change in visual fields sensitivity
Measured by static perimetry with topographical analysis.
Measured: Baseline and every year until study completion at 4 years
Change in mean retinal sensitivity
Measured by fundus-guided microperimetry.
Measured: Baseline and every year until study completion at 4 years
Change in ellipsoid zone (EZ) area
Measured by optical coherence tomography (SD-OCT).
Measured: Baseline and every year until study completion at 4 years
Change in retinal autofluorescence and Robson ring size
Measured by fundus autofluorescence imaging.
Measured: Baseline and every year until study completion at 4 years
Change in condition of the retina, macula, optic nerve and ocular vascularization
Measured by assessing stereo color fundus photography.
Measured: Baseline and every year until study completion at 4 years
Change in rod- and cone-mediated retinal function
Measured by full-field stimulus testing (FST).
Measured: Baseline and every year until study completion at 4 years
Change in retinal function
Measured by full field electroretinogram amplitudes and timing in response to rod- and cone-specific stimuli.
Measured: Baseline and study completion at 4 years
Change in hearing thresholds
Measured by pure tone audiometry (PTA) and speech audiometry.
Measured: Baseline and study completion at 4 years
Change in auditory speech recognition abilities in noise
Measured by the digits in noise test (DIN).
Measured: Baseline and study completion at 4 years
Change in integrity of the outer hair cells
Measured by otoacoustic emissions (OAEs).
Measured: Baseline and study completion at 4 years
Change in integrity of the inner hair cells, the synapse and the first stage on the auditory nerve
Measured by electrocochleography (ECochG).
Measured: Baseline and study completion at 4 years
Vestibular function
Measured by rotational chair test and calorisation.
Measured: 3 years
Function of individual vestibular semicircular canals
Measured by video head impulse test (HIT) test.
Measured: 3 years
Function of saccule and utricule of the vestibular organ
Measured by vestibular evoked myogenic potential (VEMP) test.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start11 Feb 2019
- Primary completion2 Mar 2024 (estimated)
- Study completion2 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Usher Syndrome, Type 2AStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Ushersyndroom
- Responsible party
- Sponsor
- Investigators
- Ronald Pennings, Dr, Study director, Radboud Universitair Medisch CentrumErwin van Wyk, Dr, Principal investigator, Radboud Universitair Medisch CentrumCarel Hoyng, Prof, Principal investigator, Radboud Universitair Medisch CentrumRonald Pennings, Dr, Principal investigator, Radboud Universitair Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820244
- Sponsor's protocol ID
- NL67258.091.18
- Acronym
- CRUSH
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Rate of Progression in USHer Syndrome (CRUSH) Study
- ClinicalTrials.gov ID
- NCT04820244
- Acronym / sponsor ID
- CRUSH / NL67258.091.18
- Conditions
- Usher Syndrome, Type 2A, Retinitis Pigmentosa, USH2A
- Keywords
- USH2A, Non-Syndromal USH2 related Retinitis Pigmentosa, Natural history study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Ushersyndroom
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 2 Mar 2024 (estimated)
- Study completion
- 2 Mar 2024 (estimated)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mutations in USH2A give rise to two phenotypes: Usher syndrome type 2a (USH2A) and nonsyndromic RP (USH2A associated nsRP). Usher syndrome is the most common form of congenital deafblindness. Patients with Usher syndrome are hearing impaired or profoundly deaf from birth and this can be rehabilitated with hearing aids or a cochlear implant. Furthermore, these patients develop retinitis pigmentosa (RP), a slowly progressive type of retinal degeneration that usually starts in the first or second decade of life. In both USH2A and nsRP patients the disease leads to severe visual impairment and eventually blindness around the 50th-70th year of life. There are no treatment options for the retinal degeneration. We do not know if they also suffer from balance complaints.
Currently, genetic therapy for Usher syndrome type 2 and USH2A associated nsRP is in development. But to measure the effect of a (genetic) therapy, it is crucial to know the detailed natural course of the visual and hearing deterioration over time. Several genetic therapy studies for other disorders are currently delayed, because the natural history of the disease has not been studied in detail previously.
The main objective is to map the natural course of the visual and hearing deterioration in Usher Syndrome 2 and USH2A associated nsRP for upcoming genetic therapy studies. Secondary objectives are: 1) To determine the necessary type of (combined) examinations, the sample size and length of studies (in years) essential to evaluate future genetic therapy in Usher syndrome. 2) To improve counselling of patients with Usher syndrome type 2 and USH2A associated nsRP with detailed information on the prognosis. 3) To identify additional etiological factors that explain variability in hearing impairment by adding questionnaires and psychophysical audiometric tests; and to assess the vestibular phenotype in Usher syndrome type 2 and USH2A associated nsRP patients.
This is a longitudinal, prospective natural history study. The study population consists of healthy human volunteers, 16 - 55 yr old with a confirmed genetic diagnosis of Usher Syndrome type 2 or and USH2A associated nsRP.
The main study endpoint is the natural course of the visual and hearing deterioration in Usher Syndrome type 2 and USH2A associated nsRP, over a time span of 4 years.
There are no risks associated with participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No intervention | – | Other: No interventionOtherwise healthy human volunteers, 16-55 years old, with a confirmed genetic diagnosis of Usher Syndrome type 2 or non-syndromal USH2A related retinitis pigmentosa |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The Dutch Usher syndrome population consists of an estimated 850 patients. Additionally we would like to include patients with USH2A associated nsRP. Subjects will be recruited from this population. In the past years it has been clear that patients are highly motivated to participate in research for their disease. We aim to include 50 subjects and given our past experiences, we consider this a feasible number of participants. The study population consists of both males and females between 16 and 55 years of age with a confirmed genetic diagnosis of USH2A associated RP either syndromic or nonsyndromic.
Key inclusion criteria (11 listed)
- Clinically diagnosed with rod-cone degeneration and at least two; pathogenic or likely pathogenic mutations in one of the Usher type 2 genes;
- Willing and able to complete the informed consent process;
- Ability to return for all study visits over 48 months;
- Age ≥ 16 years.
- Clinical diagnosis of a rod-cone degeneration;
Key exclusion criteria (16 listed)
- Mutations in genes that cause autosomal dominant RP, X-linked RP, or presence of biallelic mutations in autosomal recessive RP/retinal dystrophy genes other than Usher genes;
- Expected to enter experimental treatment trial at any time during this study History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy (including hydroxychloroquine, chloroquine, thioridazine, and deferoxamine).
- Current vitreous hemorrhage;
- Current or any history of rhegmatogenous retinal detachment;
- Current or any history of (e.g., prior to cataract or refractive surgery) spherical equivalent of the refractive error worse than -8 Diopters of myopia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | No intervention |
Primary outcome
Change in perceived visual functioning
Time frame: Baseline, 2 years and study completion at 4 years
Measured by the Visual Functioning Questionnaire-48 (VFQ-48): score of difficulty of performing 48 activities (items). The score is determined using two formulas: 'average item score = total item scores / (48 - U)' in which activities for which a person has non-visual reasons not to do it or in which they are not interested are scored with 'U', and '0.9*LN((2.34-average item score) / (average item score+2.22))+0.05'. The higher the score, the lower the perceived visual functioning.
Change in perceived handicap due to hearing impairment
Time frame: Baseline, 2 years and study completion at 4 years
Measured by the Speech, Spatial and Qualities of Hearing Scale (SSQ): range 0-500, the higher the score, the fewer the perceived handicap due to hearing impairment.
Change in perceived handicap due to dizziness
Time frame: Baseline, 2 years and study completion at 4 years
Measured by the Dizziness Handicap Inventory (DHI): range 0-100, the higher the score, the greater the perceived handicap due to dizziness.1. Pure tone audiometry and speech audiometry
Change in lifestyle adjustment due to Usher syndrome.
Time frame: Baseline, 2 years and study completion at 4 years
Measured by the Usher lifestyle survey: qualitative questionnaire, no quantitative measures
Change in perceived health
Time frame: Baseline, 2 years and study completion at 4 years
Measured by the 12-item Short-Form Health Survey (SF-12): 12 items with ranges 3-6, transformation of scores: ((patient score - lowest possible score)/range of scores)) * 100, the higher the score, the greater the perceived health.
Change in the indication of depressive symptoms
Time frame: Baseline, 2 years and study completion at 4 years
Measured by the Patient Health Questionnaire Mood Scale (PHQ-9): range 0-27, the higher the score, the greater the indication of depressive symptoms.
Change in overall condition of the eye
Time frame: Baseline and every year until study completion at 4 years
Measured by full ophthalmic exam.
Change in visual acuity
Time frame: Baseline and every year until study completion at 4 years
Measured by best-corrected visual acuity.
Change in visual fields area
Time frame: Baseline and study completion at 4 years
Measured by dynamic perimetry with topographical analysis.
Change in visual fields sensitivity
Time frame: Baseline and every year until study completion at 4 years
Measured by static perimetry with topographical analysis.
Change in mean retinal sensitivity
Time frame: Baseline and every year until study completion at 4 years
Measured by fundus-guided microperimetry.
Change in ellipsoid zone (EZ) area
Time frame: Baseline and every year until study completion at 4 years
Measured by optical coherence tomography (SD-OCT).
Change in retinal autofluorescence and Robson ring size
Time frame: Baseline and every year until study completion at 4 years
Measured by fundus autofluorescence imaging.
Change in condition of the retina, macula, optic nerve and ocular vascularization
Time frame: Baseline and every year until study completion at 4 years
Measured by assessing stereo color fundus photography.
Change in rod- and cone-mediated retinal function
Time frame: Baseline and every year until study completion at 4 years
Measured by full-field stimulus testing (FST).
Change in retinal function
Time frame: Baseline and study completion at 4 years
Measured by full field electroretinogram amplitudes and timing in response to rod- and cone-specific stimuli.
Change in hearing thresholds
Time frame: Baseline and study completion at 4 years
Measured by pure tone audiometry (PTA) and speech audiometry.
Change in auditory speech recognition abilities in noise
Time frame: Baseline and study completion at 4 years
Measured by the digits in noise test (DIN).
Change in integrity of the outer hair cells
Time frame: Baseline and study completion at 4 years
Measured by otoacoustic emissions (OAEs).
Change in integrity of the inner hair cells, the synapse and the first stage on the auditory nerve
Time frame: Baseline and study completion at 4 years
Measured by electrocochleography (ECochG).
Vestibular function
Time frame: 3 years
Measured by rotational chair test and calorisation.
Function of individual vestibular semicircular canals
Time frame: 3 years
Measured by video head impulse test (HIT) test.
Function of saccule and utricule of the vestibular organ
Time frame: 3 years
Measured by vestibular evoked myogenic potential (VEMP) test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Pennings, Dr study director
Radboud Universitair Medisch Centrum
Erwin van Wyk, Dr principal investigator
Radboud Universitair Medisch Centrum
Carel Hoyng, Prof principal investigator
Radboud Universitair Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Usher Syndrome, Type 2A and Retinitis Pigmentosa, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived visual functioning (time frame: Baseline, 2 years and study completion at 4 years). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.