Proton Radiation Therapy for Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 2/24/2018 |
| Start Date: | May 2013 |
| End Date: | February 2018 |
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.
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.
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.
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.
We found this trial at
1
site
2015 Jefferson St
Jacksonville, Florida 32206
Jacksonville, Florida 32206
(904) 588-1800
Principal Investigator: Roi Dagan, MD
Phone: 877-686-6009
University of Florida Proton Therapy Institute When the University of Florida Proton Therapy Institute opened...
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