Treatment -Resistant Neovascular Age-Related Macular Degeneration

Phase 1

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Rituximab

• Registration Number: NCT02332941
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Rituximab	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.

Primary Outcome Measures

Name	Time	Method
Central Macular Thickness	2 years	Primary measure will be Central Macular Thickness as recorded with Optical Coherence Tomography.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States