Randomized Trial for Retinitis Pigmentosa

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00000116
• Date of registration: 23/09/1999
• Prospective Registration: No
• Primary sponsor: National Eye Institute (NEI)
• Public title: Randomized Trial for Retinitis Pigmentosa
• Scientific title: Randomized Trial for Retinitis Pigmentosa
• Date of first enrolment: May 1996
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00000116
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Eliot Berson, MD
• Affiliation: Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School

Key inclusion & exclusion criteria

Inclusion Criteria:

Eligible patients must:

- Be between the ages of 18 and 56

- Be able to see the entire face of someone sitting across the table from them without
scanning

- Read newspaper-size print without special magnifying aids

- Walk unaided in daylight

- Have a normal fasting serum vitamin A and normal liver function profile

- Be in good general health

- Reside in the United States

Exclusion Criteria:

- Women who are pregnant or planning to become pregnant cannot be included because of
the risk of birth defects that could occur while they are on a vitamin A supplement.



Age minimum: 18 Years
Age maximum: 56 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Drug: Nutritional Supplement

Drug: Vitamin A

Secondary ID(s)

NEI-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors