Treatment -Resistant Neovascular Age-Related Macular Degeneration

NCT02332941 | Completed Phase 1 DMC

• 1 other identifier: 201406106
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Central Macular Thickness

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

  2 years

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Drug: Rituximab

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.

Single Arm

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rithwick Rajagopal, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: January 7, 2015
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)