Treatment -Resistant Neovascular Age-Related Macular Degeneration

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT02332941
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
41 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2014
Status verified
Jun 2015
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
5 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    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 Measure

Central Macular Thickness [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Washington University School of Medicine· St Louis, MO

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