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Clinical Trials/NL-OMON48655
NL-OMON48655
Recruiting
Not Applicable

Prospective clinical evaluation of inherited retinal diseases - IRD prospective

Radboud Universitair Medisch Centrum0 sites40 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inherited retinal disease
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
40
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • Study Participant Inclusion Criteria
  • Participants must meet the following:
  • 1\. Clinical diagnosis of STGD and at least two pathogenic or likely pathogenic mutations in trans in the ABCA4 gene of which at least one therapy\-eligible mutation
  • 2\. Age \>\= 16 years
  • 3\. Willing and able to complete the informed consent
  • 4\. Ability to return for all study visits over 36 months;Ocular Inclusion Criteria
  • At least one eye of participants must meet the following:
  • 1\. Baseline visual acuity ETDRS letter score of 54 or more (approximate Snellen equivalent 20/80 or better)
  • 2\. Stable fixation and ability to perform perimetry reliably
  • 3\. Clear ocular media and adequate pupil dilation to permit good quality imaging

Exclusion Criteria

  • Study Participant Exclusion Criteria
  • 1\. Mutations in genes that cause autosomal dominant or X\-linked retinal dystrophy, or presence of biallelic mutations in autosomal recessive retinal dystrophy genes other than the gene studied in the patient cohort.;Ocular Exclusion Criteria
  • If both eyes have any of the following, the patient is not eligible:
  • 1\. Current vitreous hemorrhage
  • 2\. Current or any history of rhegmatogenous retinal detachment
  • 3\. 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
  • 4\. History of intraocular surgery (e.g., cataract surgery, vitrectomy, penetrating keratoplasty, or LASIK) within the last 3 months
  • 5\. Current or any history of retinal vascular occlusion or proliferative diabetic retinopathy
  • 6\. Expected to have cataract removal surgery during the study

Outcomes

Primary Outcomes

Not specified

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