Clinical trial NCT01833325: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: Age-Related Macular Degeneration
Macular Degeneration
Proton radiation
Choroidal Neovascular Membranes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants with acute and late morbidity of the eye as a measure of safety
timeFrame: 1 year after completion of radiation treatment
measure: Number of participants with cessation of growth of neovascular membranes.
timeFrame: 1 year after completion of radiation treatment
measure: Visual acuity per comprehensive eye exam
timeFrame: 1 year after completion of radiation treatment
measure: Frequency of intravitreal injections following radiation treatment
timeFrame: 1 year after completion of radiation treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: Roi Dagan, MD,
role: PRINCIPAL_INVESTIGATOR
References:
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