Clinical Evaluation of Patients With X-linked Retinitis Pigmentosa (XLRP)
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ClinicalTrials.gov Identifier: NCT03314207 |
Recruitment Status :
Completed
First Posted : October 19, 2017
Last Update Posted : January 11, 2023
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Condition or disease |
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X-Linked Retinitis Pigmentosa |
Study Type : | Observational |
Actual Enrollment : | 14 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Clinical Evaluation of Individuals With X-linked Retinitis Pigmentosa (XLRP) Caused by RPGR-ORF15 Mutations |
Actual Study Start Date : | December 1, 2017 |
Actual Primary Completion Date : | February 10, 2022 |
Actual Study Completion Date : | February 10, 2022 |

- Disease progression in subjects with XLRP [ Time Frame: Day 0 - Month 36 ]
- Disease progression using visual acuity testing [ Time Frame: Day 0 - Month 36 ]
- Disease progression using perimetry [ Time Frame: Day 0 - Month 36 ]
- Disease progression using OCT [ Time Frame: Day 0 - Month 36 ]
- Disease progression using electroretinography [ Time Frame: Day 0 - Month 36 ]
- Disease progression using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) quality of life questionnaire [ Time Frame: Day 0 - Month 36 ]

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314207
United States, North Carolina | |
Duke Eye Center, Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Oregon | |
Casey Eye Institute, Oregon Health and Sciences University | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Retina Foundation of the Southwest | |
Dallas, Texas, United States, 75231 |
Study Director: | Matthew Feinsod, MD | Applied Genetics Technologies Corporation |
Responsible Party: | Applied Genetic Technologies Corp |
ClinicalTrials.gov Identifier: | NCT03314207 |
Other Study ID Numbers: |
AGTC-XLRP-001 |
First Posted: | October 19, 2017 Key Record Dates |
Last Update Posted: | January 11, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
XLRP retinal degeneration RPGR ORF15 |
Retinitis Retinitis Pigmentosa Retinal Diseases Eye Diseases |
Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn |