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Proton Radiation Therapy for Macular Degeneration

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton radiation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age-Related Macular Degeneration, Macular Degeneration, Proton radiation, Choroidal Neovascular Membranes

Eligibility Criteria

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

Sites / Locations

  • University of Florida Proton Therapy Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton radiation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 27, 2013
Last Updated
February 21, 2018
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01833325
Brief Title
Proton Radiation Therapy for Macular Degeneration
Official Title
A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Age-Related Macular Degeneration, Macular Degeneration, Proton radiation, Choroidal Neovascular Membranes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proton radiation
Arm Type
Experimental
Arm Description
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
Intervention Type
Radiation
Intervention Name(s)
Proton radiation
Intervention Description
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
Primary Outcome Measure Information:
Title
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
Title
Number of participants with cessation of growth of neovascular membranes.
Time Frame
1 year after completion of radiation treatment
Title
Visual acuity per comprehensive eye exam
Time Frame
1 year after completion of radiation treatment
Title
Frequency of intravitreal injections following radiation treatment
Time Frame
1 year after completion of radiation treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roi Dagan, MD,
Organizational Affiliation
University of Florida Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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Bressler NM; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two-year results of 2 randomized clinical trials-tap report 2. Arch Ophthalmol. 2001 Feb;119(2):198-207.
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Proton Radiation Therapy for Macular Degeneration

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