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NCT01086631 · ClinicalTrials.gov registry record · Phase 1

Rituximab for Autoimmune Retinopathy

A Phase 1 study, sponsored by National Eye Institute (NEI).

Completed
Registry status
Phase 1
Development phase
5
Enrollment target

NCT01086631: Completed Phase 1 study, sponsored by National Eye Institute (NEI).

NCT01086631 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01086631, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

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.

Interventions

  • DRUG Rituximab

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2010-01-22
Est. Completion 2014-07-08
Phase Phase 1
National Eye Institute (NEI)

221 total trials

What the finished NCT01086631 record still lists

NCT01086631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.

NCT01086631 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01086631 about?

NCT01086631 is a clinical study titled "Rituximab for Autoimmune Retinopathy". 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...

What is the current status of trial NCT01086631?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-01-22. Estimated completion is 2014-07-08.

What interventions are being tested in trial NCT01086631?

The interventions under investigation include: Rituximab (DRUG).

Who is sponsoring clinical trial NCT01086631?

This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01086631's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01086631, the US trial registry maintained by the National Library of Medicine. NCT01086631 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.