Rituximab for Autoimmune Retinopathy
Completed · Phase 1
Conditions studied: Autoimmune Disease
In brief
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.
Key facts
- Study ID
- NCT01086631
- Run by
- National Eye Institute (NEI)
- People needed
- 5
- Starts
- 2010-01-22
- Expected to finish
- 2014-07-08
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Participant received other biologic agents (e.g., infliximab, daclizumab or adalimumab) within three months prior to study enrollment.
- Participant is receiving more than two immunosuppressive agents or experienced a change in his/her AIR immunosuppressive medication regimen within the two months prior to enrollment.
- Participant received intraocular or periocular steroid injections within two months prior to study enrollment.
- Participant has a significant active infection (an infection requiring treatment as determined by the medical team) or a history of chronic or recurrent infections.
- Participant is HIV positive or has syphilis.
- Participant has a history of cancer (other than a non-melanoma skin cancer or non-Hodgkin s lymphoma [NHL]) diagnosed within the past five years.
- Participant has or is a carrier of hepatitis B or C.
- Participant has a known hypersensitivity to sodium fluorescein dye.
- Participant has congestive heart failure, abnormal cardiac function or significant pulmonary disease.
- Participant is participating in another simultaneous investigational product treatment trial.
- Participant received a live or live-attenuated vaccine within the previous four weeks prior to study enrollment
- Participant had ocular surgery within 60 days prior to study enrollment or is anticipated to require elective intraocular surgery.
- Participant has inadequately controlled diabetes.
- Participant has a condition that, in the opinion of the investigator, would pose a significant hazard to the participant if the investigational product was initiated.
- Participant has any other condition that would be contraindicated to treatment with rituximab or their current immunosuppressive agent.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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