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Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants

Sponsor: Jaeb Center for Health Research

NCT ID: NCT05589714

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 91 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This is a registry and natural history study looking at inherited retinal conditions, including retinitis pigmentosa, caused by rare genetic changes. It is run by the Jaeb Center for Health Research. It aims to collect information over time rather than test a new treatment.

Who can take part

  • Aged 4 or over
  • Able and willing to give consent and complete the study checks
  • Have a genetic report showing a disease-causing gene change that meets the study's genetic rules (from a certified lab or an approved research lab)
  • Both eyes have a diagnosis of retinal dystrophy
  • Both eyes can be photographed with good-quality images (for example, clear eye fluids and wide-enough pupils)

Who may not be able to

  • More than 1 year of total past treatment with certain drugs linked to retinal damage, such as amiodarone, chloroquine, hydroxychloroquine, tamoxifen or deferoxamine
  • Bleeding in the eye (vitreous haemorrhage) at the screening visit
  • Eye problems from severe short-sightedness that would stop good photographs being taken
  • Eye surgery (such as cataract surgery or laser eye surgery) within the last 3 months
  • Glaucoma now or in the past
  • Blocked retinal blood vessels, or proliferative diabetic retinopathy, now or in the past
  • Other eye conditions that, in the study doctor's view, could affect tests of vision
  • Any previous stem cell or gene therapy in the eye, treatment with ocriplasmin, or certain steroid implants in the eye (Ozurdex, Iluvien or Yutiq)
  • Ophthalmic oligonucleotide treatment in the last 9 months, or certain other treatments within five times the length the drug stays in the body
  • Pregnant under-18s cannot take part until they reach adulthood (pregnant adults are not excluded)

What taking part involves

  • • This is an observational study, so you would not receive a treatment as part of it. The study collects information and images of your eyes over time.

Time commitment: Not fully stated — it involves a registry/screening visit with eye assessments and photographic imaging of both eyes; ask the trial team how many visits there are and how long the study lasts.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
4 Years and over
Who
All
Number of participants
1,500
Started
2023-05-11
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for inherited retinal degeneration
  • • Clinical study - 1,500 participants
  • • This is an international, multicenter study with two components: Registry * A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection * Enrollment is open to all genes on the RD Rare Gene List Natural History Study * A prospective, standardized, longitudinal Natural History Study * Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows

Who can take part?

  • • Ages 4 Years and over
  • • Diagnosed with inherited retinal degeneration

Where?

  • • London - Moorfields Eye Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is an international, multicenter study with two components: Registry * A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection * Enrollment is open to all genes on the RD Rare Gene List Natural History Study * A prospective, standardized, longitudinal Natural History Study * Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows. Registry Objectives 1. Genotype Characterization 2. Cross-Sectional Phenotype Characterization (within gene) 3. Establish a Link to My Retina Tracker Registry (MRTR) 4. Ancillary Exploratory Studies - Pooling of Genes Natural History Study Objectives 1. Natural History (within gene) 2. Structure-Function Relationship (within gene) 3. Risk Factors for Progression (within gene) 4. Ancillary Exploratory Studies - Pooling of Genes

More detail

This study includes multiple phases. 1. Screening Phase The patient's current genetic report will be reviewed. Genetic testing will not be performed in this study. A prior conclusive genetic test will be assessed for screening analysis. Having at least one gene on the RD Rare Gene List meets one of the eligible Genetic Screening Criteria and other eligibility criteria can be evaluated based on medical history. 2. Genetic Screening Phase: Genetic reports for participants enrolled into the genetic screening phase will be uploaded to study website for review and confirmation by Central Genetics Auditor (CGA) as meeting Genetic Screening Criteria.Participants confirmed as meeting those criteria will be considered enrolled into the Registry. 3. Registry Phase: The flow of participants who are enrolled into the Registry depends on whether their causal gene is designated as a Natural History Study (NHS) Target Gene. If they are not Designated as NHS Target Gene, they will receive annual phone calls up to 48 months from the Registry/Screening visit or until the gene is designated as NHS Target Gene. If they are Designated as NHS Target Gene participants will be considered pending enrollment into the NHS. The Registry will establish genetically and clinically well-characterized cohorts of patients across hundreds of genetic variants associated with retinal dystrophy (RD). Characterization of these patients will accelerate eligibility screening for the Natural History Study, provide cross-sectional data on phenotype-genotype associations, and contribute to our knowledge of pathogenicity of these rare disease-causing variants. 4. Natural History Study (NHS) Phase Participants pending enrollment will return to the clinic for the NHS Enrollment/Baseline Visit and return to the clinic for follow-up visits. The Natural History Study will accelerate the identification and development of sensitive, reliable outcome measures for clinical trials, which will facilitate development of treatments for retinal dystrophies due to disease-causing genetic variants. The expected impact of the Natural History Study is as follows: 1. Describe the natural history of retinal degeneration in patients with rare disease-causing genetic variants 2. Identify sensitive structural and functional outcome 3. Identify well-defined subpopulations for future clinical trials of investigative treatments for rare inherited retinal degeneration

Inherited Retinal DegenerationRetinitis Pigmentosa

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 4 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ a clinical diagnosis of retinal dystrophy

Treatments you must NOT have had:

  • ✗ the following treatments:

What the study is looking for

  • ✓Participants must meet all the following inclusion criteria at the Registry/Screening Visit to be eligible to enroll...
  • ✓Willing to participate in the study and able to communicate consent during the consent process
  • ✓Willing and able to complete all applicable Registry/Screening Visit assessments
  • ✓Age ≥ 4 years
  • ✓Inheritance Pattern is Recessive and has at least 2 disease-causing variants which are homozygous or heterozygous in...

Who cannot take part

  • ✗Participants must not meet any of the following exclusion criteria at the Registry/Screening Visit to be eligible to...
  • ✗Ocular Exclusion Criteria:
  • ✗If either eye has any of the following ocular exclusion criteria at the Registry/Screening Visit, then the...
  • ✗Current vitreous hemorrhage
  • ✗History of intraocular surgery (for example, but not limited to, cataract surgery, vitrectomy, penetrating...
See the full criteria
Inclusion Criteria: Participants must meet all the following inclusion criteria at the Registry/Screening Visit to be eligible to enroll into the genetic screening phase: 1. Willing to participate in the study and able to communicate consent during the consent process 2. Willing and able to complete all applicable Registry/Screening Visit assessments 3. Age ≥ 4 years 4. Must have a single gene on the RD Rare Gene List which meets one of the Genetic Screening Criteria below based on a genetic report\* from a clinically certified lab (or from a research lab which has been approved by the study Genetics Committee): Inheritance Pattern is Recessive and has at least 2 disease-causing variants which are homozygous or heterozygous in trans OR Inheritance Pattern is Recessive and has 2 disease-causing variants with unknown phase and meets all the following additional informatic criteria that is consistent with likely segregation in trans: 1. Investigator confirms genotype and phenotype are consistent with autosomal recessive inheritance 2. The 2 disease-causing variants have not been reported in cis in variant databases 3. No additional potentially pathogenic variants were found on the gene (and the sequencing data for the gene were sufficiently robust to detect any additional potentially pathogenic variants) 4. No potentially pathogenic variants were found in other common, likely candidate genes for the proposed condition OR Inheritance Pattern is Dominant, X-linked, or Mitochondrial and has at least 1 disease-causing variant Both eyes must meet the following criteria at the Registry/Screening Visit to enroll into the genetic screening phase: 1. Both eyes must have a clinical diagnosis of retinal dystrophy 2. Both eyes must permit good quality photographic imaging (e.g., but not limited to, clear ocular media, adequate pupil dilation, stable fixation) Exclusion Criteria: Participants must not meet any of the following exclusion criteria at the Registry/Screening Visit to be eligible to enroll into the genetic screening phase: 1\. History of more than 1 year of cumulative treatment, at any time, with an agent associated with pigmentary retinopathy including amiodarone, chloroquine, deferoxamine, hydroxychloroquine, pentosan polysulfate, tamoxifen, and deferoxamine Note: Since this is an observational study, pregnant women will not be specifically excluded from participation. However, minors that are pregnant shall be precluded from participation until they become the age of majority. Ocular Exclusion Criteria: If either eye has any of the following ocular exclusion criteria at the Registry/Screening Visit, then the participant is not eligible to enroll into the genetic screening phase: 1. Current vitreous hemorrhage 2. Current complications of pathological myopia (for example, but not limited to, myopic maculopathy including atrophy, scar, choroidal neovascularization, schisis) that could inhibit ability to obtain good quality photographic imaging 3. History of intraocular surgery (for example, but not limited to, cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within 3 months of Registry/Screening Visit 4. Current or any history of confirmed diagnosis of glaucoma (for example, but not limited to, glaucomatous VF changes or nerve changes, or history of glaucoma filtering surgery) 5. Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy 6. History or current evidence of ocular disease that, in the opinion of the Investigator, may confound assessment of visual function (for example, but not limited to, tractional or rhegmatogenous retinal detachment, any vitreoretinal surgery, retinal vascular occlusion, proliferative diabetic retinopathy) 7. The following medications and treatments are prohibited as they can affect progression of retinitis pigmentosa (RP). The participant must not have received the following treatments: Any use of ocular stem cell or gene therapy Any treatment with ocriplasmin Treatment with Ozurdex (dexamethasone), Iluvien, or Yutiq (fluocinolone acetonide) intravitreal implant 8. The following medications and treatments are excluded within the specified timeframe: Treatment with an ophthalmic oligonucleotide within the last 9 months (last treatment date is less than 9 months prior to Registry/Screening Visit date) Treatment with any other product within five times the expected half-life of the product (time from last treatment date to Registry/Screening Visit date is at least 5 times the half-life of the given product)

Where Is This Study? (1 UK site)

Moorfields Eye Hospital

London EC1V 2PD, United Kingdom

Recruiting
Site contact (verified)
Michel Michaelides, MD02075662108nusrat.haque3@nhs.net

How to Get in Touch

Coordinating Center

Sponsor contact

CONTACT

813-975-8690 ffb@jaeb.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-06