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Clinical Trials in Italy / NCT05589714
Recruiting Observational

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

NCT05589714 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-05-11
Last updated
2026-09-08

Condition(s) studied

Inherited Retinal DegenerationRetinitis Pigmentosa

Study summary

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

Eligibility

Sex
ALL
Min age
4 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
University of Arkansas, Jones Eye Institute Little Rock Arkansas Recruiting
USC Roski Eye Institute Los Angeles California Recruiting
University of California San Francisco San Francisco California Recruiting
University of Florida Health Jacksonville Jacksonville Florida Recruiting
University of Miami, Bascom Palmer Eye Institute Miami Florida Recruiting
Emory University, Emory Eye Center Atlanta Georgia Recruiting
Johns Hopkins University, Wilmer Eye Institute Baltimore Maryland Recruiting
Harvard Univ., Massachusetts Eye and Ear Infirmary Boston Massachusetts Recruiting
University of Michigan, Kellogg Eye Center Ann Arbor Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Duke University, Duke Eye Center Durham North Carolina Recruiting
Oregon Health & Science Univ., Casey Eye Institute Portland Oregon Recruiting
University of Pennsylvania, Scheie Eye Institute Philadelphia Pennsylvania Recruiting
UPMC Eye Center Pittsburgh Pennsylvania Recruiting
Retina Foundation of the Southwest Dallas Texas Recruiting
Baylor College of Medicine, Alkek Eye Center Houston Texas Recruiting
University of Utah, John Moran Eye Center Salt Lake City Utah Recruiting
University of Wisconsin Madison Madison Wisconsin Recruiting
Medical College of Wisconsin Eye Institute Milwaukee Wisconsin Recruiting
Centre for Eye Research Australia East Melbourne Victoria Recruiting
Ghent University Ghent Belgium Not Yet Recruiting
INRET Clínica e Centro de Pesquisa Belo Horizonte Minas Gerais Recruiting
Instituto de Genética Ocular São Paulo São Paulo Province Recruiting
University of Alberta and Alberta Health Services Edmonton Alberta Recruiting
University of Toronto, Hospital for Sick Children Toronto Ontario Recruiting
University Health Network Toronto Canada Recruiting
Helsinki University Hospital Helsinki Finland Recruiting
CHNO des Quinze-Vingts Paris France Recruiting
Hadassah-Hebrew University Medical Center Jerusalem Israel Recruiting
Vista Vision Eye Clinic Brescia Italy Recruiting
Retina and Genomics Institute Yucatán Merida Recruiting
Radboud University Medical Center Nijmegen Netherlands Recruiting
Oslo University Hospital Oslo Norway Recruiting
University Hospital Basel Basel Canton of Basel-City Recruiting
University Hospital Jules-Gonin Lausanne Switzerland Recruiting
Moorfields Eye Hospital London United Kingdom Recruiting

More Jaeb Center for Health Research trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05589714 on ClinicalTrials.gov ↗ ← All trials in Italy