Status:
COMPLETED
Clinical Evaluation of Patients With X-linked Retinitis Pigmentosa (XLRP)
Lead Sponsor:
Beacon Therapeutics
Conditions:
X-Linked Retinitis Pigmentosa
Eligibility:
MALE
6+ years
Brief Summary
The purpose of this study is to evaluate subjects with X-linked retinitis pigmentosa caused by RPGR-ORF15 mutations in a clinical setting to fully characterize their condition, measure testing variabi...
Detailed Description
Males with a clinical diagnosis of X-linked retinitis pigmentosa (XLRP) caused by RPGR-ORF15 mutations will be asked to provide informed consent and will have a single blood or saliva sample obtained ...
Eligibility Criteria
Inclusion
- Male subjects with a clinical diagnosis of XLRP and a documented molecular diagnosis from a CLIA-certified laboratory of mutation within the ORF15 exon of the RPGR gene;
- At least 6 years of age;
- Willing and able to perform study procedures;
- Signed informed consent(s) obtained (and child assent where applicable).
Exclusion
- Pre-existing eye conditions that would interfere with interpretation of study endpoints (e.g. glaucoma, corneal or lenticular opacities, diabetic retinopathy, history of retinal detachment);
- Participating in an interventional research study of drugs or devices for treatment of XLRP or other retinal diseases;
- Monoocular participants
- Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03314207
Start Date
December 1 2017
End Date
February 10 2022
Last Update
January 11 2023
Active Locations (3)
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1
Duke Eye Center, Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Casey Eye Institute, Oregon Health and Sciences University
Portland, Oregon, United States, 97239
3
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231