Effect of DHA Supplements on Macular Function in Patients With Stargardt Macular Dystrophy and Stargardt-like Macular Dystrophy

Launched by NATIONAL EYE INSTITUTE (NEI) · May 9, 2003

Keywords

ClinConnect Summary

We propose to undertake a double-masked, randomized, placebo-controlled, crossover study on the effect of docosahexaenoic acid (DHA) dietary supplementation in subjects with macular dystrophy to determine whether DHA can improve macular function. Subjects will receive either oral DHA supplementation (5x200 mg BID, 2,000 mg/day) or placebo. Subjects will 'crossover' to the opposite treatment twice during this study. Primary outcomes will measure the change in macular function during periods with and without DHA supplementation.

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Eligibility criteria

• * INCLUSION CRITERIA:
• • To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria.
• • 1. Understand and sign the informed consent.
• • 2. Able to comply with all study procedures (likely to exclude participants less than 10 years of age, but not necessarily).
• Autosomal Recessive Stargardt Macular Dystrophy Participants (must be observed in at least one study eye):
• • 3. Have a pattern of inheritance that indicates autosomal recessive inheritance.
• • 4. Have a phenotype consistent with the diagnosis of autosomal recessive Stargardt macular dystrophy including the following clinical features: fundus examination showing bilateral central maculopathy and/or fundus flecks, or characteristic changes on an intravenous fluorescein angiogram.
• Autosomal Dominant Stargardt-like Macular Dystrophy Participants (must be observed in at least one study eye):
• • 5. Have a pattern of inheritance that indicates autosomal dominant inheritance.
• • 6. Have a phenotype consistent with the diagnosis of Stargardt-like macular dystrophy that may include: fundus examination showing bilateral central maculopathy and fundus flecks confined to the central macula, or intravenous fluorescein angiogram.
• EXCLUSION CRITERIA:
• • To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria.
• • 1. Have a non-recordable multi-focal ERG.