Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03396042
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2017-12-04
Brief Title:
Natural History Study of CEP290-Related Retinal Degeneration
Sponsor:
Editas Medicine Inc
Organization:
Editas Medicine Inc
Study Overview
Official Title:
Natural History Study of CEP290-Related Retinal Degeneration
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective natural history study with systematic assessments and uniform follow-up to provide a high-quality dataset for assisting in the design of future clinical treatment trials involving patients with CEP290-related retinal degeneration caused by the common intron 26 mutation
Detailed Description:
The purpose of the study is to describe the natural history of CEP290-related retinal degeneration caused by a compound heterozygous or homozygous intron 26 c29911655AG mutation and to better understand the best assessments for evaluation of patients with this condition in a future interventional trial Patients meeting the entry criteria will be enrolled in the study Visits will occur at Screening Baseline and Months 3 6 and 12 for a total duration of 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None