Treatment -Resistant Neovascular Age-Related Macular Degeneration

Macular Degeneration Clinical Trial

— Rituximab  

Official title:

Intravitreal Rituximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332941
• Other study ID #: 201406106
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2014
• Last updated: June 1, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Macular Thickness	Primary measure will be Central Macular Thickness as recorded with Optical Coherence Tomography.	2 years	No