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High Dose DHA in X-Linked Retinitis Pigmentosa
NCT00100230Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- May 2012
- Countries
- 1
- Sponsor
- Retina Foundation of the Southwest
- Modality
- Small Molecules
- Drugs
- docosahexaenoic acid
- Conditions
- retinitis pigmentosa (RP)
01
Overview
Phase 2, randomised, double-blind trial in retinitis pigmentosa (RP) comparing DHA Group with Placebo Group (2 arms). Primary endpoint: Rate of LOSS of 31 Hertz Cone Electroretinographic Function at 4 years. Started Sep 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
DHA Group
High dose docosahexaenoic acid
Placebo Group
Corn/soy oil placebo
03
Who it enrols
Male patients aged 7-32 with X-linked Retinitis Pigmentosa and measurable cone ERG responses.
04
Endpoints
Primary
Rate of LOSS of 31 Hertz Cone Electroretinographic Function
Secondary
Rate of LOSS of Rod Electroretinographic Function
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