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Proton Radiation Therapy for Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833325
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Radiation: Proton radiation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration
Study Start Date : May 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Proton radiation
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
 Radiation: Proton radiation
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833325


Locations
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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Roi Dagan, MD, University of Florida Proton Therapy Institute
More Information
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Publications:
Macular Degeneration Foundation Adult Macular Degeneration. Available at: http://www.eyesight.org/Macular_Degeneration/Adult_MD/adult_md.html. Accessed March 8, 2012.
Yonemoto LT, Slater JD, Blacharski P, Archambeau JO, Loredo LN, Oeinck SC, Teichman S, Moyers M, Slater JM. Dose Response in the Treatment of Subfoveal Choroidal Neovascularization in Age-Related Macular Degeneration: Results of a Phase I/II Dose-Escalation Study Using Proton Radiotherapy. Journal of Radiosurgery. 2000;3(1):47-54. DOI: 10.1023/A:1009525220716

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01833325    
Other Study ID Numbers: UFPTI 1206-EY01
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Age-Related Macular Degeneration
Macular Degeneration
Proton radiation
Choroidal Neovascular Membranes
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases