Treatment -Resistant Neovascular Age-Related Macular Degeneration (Rituximab)

The Washington University

Status and phase: Completed; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT02332941

201406106

Details and patient eligibility

About

The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective. To address this issue, investigators propose a clinical trial in which patients with late stage disease, poor vision and who have failed treatment by conventional means will receive rituximab by direct injection into the affected eye and will be followed for improvement in the structure of their retina. Age Related Macular Degeneration (AMD) is a leading cause of vision loss in the elderly with routine care involving injections in the eye to improve and to prevent worsening of vision. However, some patients do not respond to the medications that we currently have and as such an alternative medication is needed. One potential medication is rituximab, which has been injected into the eye for primary eye cancer, and has been tolerated well and led to patient improvement. Investigators will obtain baseline eye tests then plan on injecting this medication in to the eye of our patients with late stage AMD, by first placing numbing drops into the eye, then injecting the medication directly into the eye using sterile techniques. Investigators will then follow the patient and repeat eye tests to monitor for improvements.

Enrollment: 5 estimated patients

Sex: All

Ages: 41+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over the age of 40
• Patients who have a diagnosis of wet age-related macular degeneration
• Patients who have a central visual acuity ,20/200
• Patients who have been deemed "treatment-resistant" at the discreation of the treating physician

Exclusion criteria

• Patients with treatment failure for neovascular AMD
• Patients who have tried multiple anti-vegf medication without anatomical or objective improvement

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single Arm

Experimental group

Description:

This is a pilot study. It will be an interventional, prospective, observational, clinical study that seeks to evaluate the effect of intravitreal rituximab over a period of one month.

Treatment:

Drug: Rituximab