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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 28, 2014
Last Updated
June 1, 2015
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02332941
Brief Title
Treatment -Resistant Neovascular Age-Related Macular Degeneration
Acronym
Rituximab
Official Title
Intravitreal Rituximab
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective.
Primary Outcome Measure Information:
Title
Central Macular Thickness
Description
Primary measure will be Central Macular Thickness as recorded with Optical Coherence Tomography.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rithwick Rajagopal, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment -Resistant Neovascular Age-Related Macular Degeneration

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