Proton Radiation Therapy for Macular Degeneration

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Radiation: Proton radiation

• Registration Number: NCT01833325
• Lead Sponsor: University of Florida

Brief Summary

This is a pilot study to determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane (SNVM). The study will include adult patients over the age of 50 with macular degeneration, who have subfoveal neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of this study are to see if the growth of neovascular membranes can be stopped and overall vision improved with the use of protons and assess the side effects associated with this treatment.

Detailed Description

As part of this study, participants will have had a standard of care comprehensive eye exam by an Ophthalmologist to include visual acuity, fundus photography, fluorescein angiography and optical coherence tomography prior to treatment.

Participants will receive radiation using protons for 2 consecutive days. Each treatment will take 30 minutes. They will receive a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments. A total of 10 participants will be enrolled on this study.

A comprehensive eye exam by an Ophthalmologist will be performed 30 days after radiation treatment with protons. Additionally, a physical examination per a Radiation Oncologist including a toxicity evaluation and comprehensive eye exam by an Ophthalmologist will be performed every 3 months for 1 year following radiation treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Study Start: 2013-05
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Patients with subfoveal neovascular membranes identified on fluorescein angiography.
• Visual acuity (best corrected vision) 20/200 or worse in affected eye.
• Patient must be 50 years of age or older at time of consent.
• Patients must have had prior treatment for macular degeneration with Avastin (bevacizumab) or Lucentis (ranibizumab).
• Women must be post menopausal or have had a hysterectomy.

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Exclusion Criteria

• History of diabetes.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton radiation	Proton radiation	Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments

Primary Outcome Measures

Name	Time	Method
Visual acuity per comprehensive eye exam	1 year after completion of radiation treatment
Number of participants with cessation of growth of neovascular membranes.	1 year after completion of radiation treatment
Frequency of intravitreal injections following radiation treatment	1 year after completion of radiation treatment
Number of participants with acute and late morbidity of the eye as a measure of safety	1 year after completion of radiation treatment

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States