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OpenTrials
Completed

NCT Number: NCT02332941

Treatment -Resistant Neovascular Age-Related Macular Degeneration

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.

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Key information

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective.

Primary outcomes

  1. Central Macular Thickness

    Time frame: 2 years

    Primary measure will be Central Macular Thickness as recorded with Optical Coherence Tomography.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Intravitreal Rituximab

Acronym: Rituximab

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.