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Rituximab for Autoimmune Retinopathy

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Contents

clinicaltrials.gov/study/NCT01086631
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT010866310
Health Conditions in Trial
Autoimmune disease
Autoimmune disease
0
Trial Recruitment Size
50
Clinical Trial Start Date
January 22, 2010
0
Study Completion Date
July 8, 2014
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 10
Official Name
Rituximab for Autoimmune Retinopathy0
Last Updated
July 5, 2018
0
Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary

Background: * Autoimmune retinopathy (AIR) is an inflammatory condition in which the patient s own immune system is attacking his or her eyes and causing vision loss. Patients with AIR are generally treated with immunosuppressive agents to treat the eye inflammation; however, the standard treatment for this disease is still being developed. * Rituximab, an immunosuppressive agent, is a monoclonal antibody that is directed against a part of the immune system that may be an important cause of AIR. Rituximab is approved for the treatment of non-Hodgkin s lymphoma and rheumatoid arthritis, but is not approved for the treatment of AIR. Researchers are interested in determining whether rituximab may be used to treat AIR. Objectives: - To to investigate the safety, tolerability and possible efficacy of rituximab as a treatment for AIR. Eligibility: - Individuals at least 18 years of age who have been diagnosed with AIR and have visual acuity of 20/200 or better in at least one eye. Design: * Before the start of the study, participants will be screened with a medical history, immunization records, a series of eye examinations, a chest X-ray, an electrocardiogram, and blood tests. * Participants will receive a maximum of two cycles of rituximab during the 18-month study. Each cycle will involve two separate intravenous infusions of rituximab given 2 weeks apart. * Participants will return to the clinic 6 weeks after the first cycle of rituximab for a safety visit, which will include a routine eye and physical examinations. They will also provide blood and other samples for study. * After the safety visit, participants will return every 3 months for follow-up visits. * At the 6-month visit, participants who have successfully or partially responded to rituximab will receive another cycle of treatment. Those who do not respond will not receive another cycle, but will continue to be monitored until the end of the study.

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