Trial record 9 of 375 for:    macular degeneration | Open Studies

Proton Radiation Therapy for Macular Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01833325
First received: March 27, 2013
Last updated: March 3, 2016
Last verified: March 2016

March 27, 2013
March 3, 2016
May 2013
March 2018   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of participants with cessation of growth of neovascular membranes. [ Time Frame: 1 year after completion of radiation treatment ] [ Designated as safety issue: No ]
  • Visual acuity per comprehensive eye exam [ Time Frame: 1 year after completion of radiation treatment ] [ Designated as safety issue: Yes ]
  • Frequency of intravitreal injections following radiation treatment [ Time Frame: 1 year after completion of radiation treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01833325 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Proton Radiation Therapy for Macular Degeneration
A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related 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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age-Related Macular Degeneration
Radiation: Proton radiation
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
Experimental: Proton radiation
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
Intervention: Radiation: Proton radiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
March 2018
March 2018   (final data collection date for primary outcome measure)

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.
Both
50 Years and older   (Adult, Senior)
No
Contact: Intake Coordinator 877-686-6009
United States
 
NCT01833325
UFPTI 1206-EY01
Yes
Not Provided
Not Provided
University of Florida
University of Florida
Not Provided
Principal Investigator: Roi Dagan, MD, University of Florida Proton Therapy Institute
University of Florida
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP