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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00060749
• Date of registration: 09/05/2003
• Prospective Registration: No
• Primary sponsor: National Eye Institute (NEI)
• Public title: Effect of DHA Supplements on Macular Function in Patients With Stargardt Macular Dystrophy and Stargardt-like Macular Dystrophy
• Scientific title: Investigation of the Effect of Dietary Docosahexaenoic Acid (DHA) Supplementation on Macular Function in Subjects With Autosomal Dominant Stargardt-Like and Autosomal Recessive Stargardt Macular Dystrophy
• Date of first enrolment: May 5, 2003
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00060749
• Study type: Interventional
• Study design: Primary purpose: Treatment.
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Macular Degeneration

Intervention(s)

Drug: Docosahexaenoic Acid (DHA) Dietary Supplement

Secondary ID(s)

03-EI-0179

030179

Source(s) of Monetary Support

Please refer to primary and secondary sponsors