Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100230
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2004-12-27
Brief Title:
DHA and X-Linked Retinitis Pigmentosa
Sponsor:
Retina Foundation of the Southwest
Organization:
Retina Foundation of the Southwest
Study Overview
Official Title:
Investigation of Effectiveness and Safety of High Dose Docosahexaenoic Acid DHA in X-Linked Retinitis Pigmentosa
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Purpose
Retinitis pigmentosa RP is characterized by progressive loss of visual function due to specific genetic mutations This trial is focused on patients with one of the most severe forms of the disease X-linked inherited RP XLRP This disease is characterized by early onset typically loss of night vision as a child followed by loss of peripheral vision as a teenager and young adult There is no male-to-male transmission of the disease in the family
There is no cure for RP and treatment options are limited Two clinical trials have not found a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid docosahexaenoic acid DHA at low daily doses although there is evidence that it slows disease progression in certain instances In this clinical trial we propose that a high dose nutritional DHA supplement will slow the loss of visual function and preserve usable vision in patients with XLRP
This study is a 4-year placebo-controlled randomized clinical trial meaning that patients have a 50-50 chance of receiving placebo or experimental treatment A total of 66 patients will be enrolled 33 will receive placebo and 33 will receive the treatment Entry criteria include diagnosis of XLRP by an ophthalmologist age 7 to 32 years male sufficient visual function such that disease progression can be followed for the entire duration of the trial and a willingness to visit the testing site Dallas TX once a year
Annual visual function testing includes ETDRS visual acuity full-field and multifocal electroretinography ERG static peripheral visual fields and fundus photography Cone ERG function is the primary outcome measure
Funding Source - FDA Foundation Fighting Blindness DSM Nutritionals
Retinitis pigmentosa RP is characterized by progressive loss of visual function due to specific genetic mutations This trial is focused on patients with one of the most severe forms of the disease X-linked inherited RP XLRP This disease is characterized by early onset typically loss of night vision as a child followed by loss of peripheral vision as a teenager and young adult There is no male-to-male transmission of the disease in the family
There is no cure for RP and treatment options are limited Two clinical trials have not found a benefit from nutritional supplementation with the long-chain polyunsaturated fatty acid docosahexaenoic acid DHA at low daily doses although there is evidence that it slows disease progression in certain instances In this clinical trial we propose that a high dose nutritional DHA supplement will slow the loss of visual function and preserve usable vision in patients with XLRP
This study is a 4-year placebo-controlled randomized clinical trial meaning that patients have a 50-50 chance of receiving placebo or experimental treatment A total of 66 patients will be enrolled 33 will receive placebo and 33 will receive the treatment Entry criteria include diagnosis of XLRP by an ophthalmologist age 7 to 32 years male sufficient visual function such that disease progression can be followed for the entire duration of the trial and a willingness to visit the testing site Dallas TX once a year
Annual visual function testing includes ETDRS visual acuity full-field and multifocal electroretinography ERG static peripheral visual fields and fundus photography Cone ERG function is the primary outcome measure
Funding Source - FDA Foundation Fighting Blindness DSM Nutritionals
Detailed Description:
Location Contact Information
Retina Foundation of the Southwest 9600 N Central Expressway Suite 200 Dallas TX 75231 Contact Dr D Hoffman dhoffmanretinafoundationorg or Dr D Birch dbirchretinafoundationorg
Retina Foundation of the Southwest 9600 N Central Expressway Suite 200 Dallas TX 75231 Contact Dr D Hoffman dhoffmanretinafoundationorg or Dr D Birch dbirchretinafoundationorg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-002543 | None | None | None |
| 5R01FD002543 | FDA | None | None |
| C-TX02-0704-0274 | OTHER_GRANT | Foundation Fighting Blindness | httpsreporternihgovquickSearch5R01FD002543 |