Proton Radiation Therapy for Macular Degeneration

University of Florida

Status: Completed

Conditions: Age-Related Macular Degeneration

Treatments: Radiation: Proton radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01833325

UFPTI 1206-EY01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• History of diabetes.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Proton radiation

Experimental group

Description:

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

Treatment:

Radiation: Proton radiation