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OpenTrials
Completed

NCT Number: NCT01833325

Proton Radiation Therapy for Macular Degeneration

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proton Radiation

Radiation

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

Primary outcomes

  1. Number of participants with acute and late morbidity of the eye as a measure of safety

    Time frame: 1 year after completion of radiation treatment

  2. Number of participants with cessation of growth of neovascular membranes.

    Time frame: 1 year after completion of radiation treatment

  3. Visual acuity per comprehensive eye exam

    Time frame: 1 year after completion of radiation treatment

  4. Frequency of intravitreal injections following radiation treatment

    Time frame: 1 year after completion of radiation treatment

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2013
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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