Status:
COMPLETED
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Exudative Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the hypothesis that proton beam irradiation combined with intravitreal anti-VEGF therapy is safe and potentially more effective than intravitreal anti-VEGF therapy...
Detailed Description
Radiation combined with anti-VEGF therapy has been shown to be synergistic in treating cancer and result in sustained tumor regression. On-going clinical trials have shown potential synergism between ...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 50 years
- Patient related considerations
- Able to maintain follow-up for at least 24 months.
- Women must be postmenopausal without a period for at least one year.
- Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), newly diagnosed or treated with first dose of anti-VEGF therapy within 6 weeks of enrollment
- Visual acuity 20/40 to 20/400
- Lesion size \< 12 Disc Area
- Submacular hemorrhage less than 75% of total lesion and not involving foveal center
- Submacular fibrosis less than 25% of total lesion
- Candidate for intravitreal anti-VEGF therapy
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- Prior enrollment in the study
- Pregnancy (positive pregnancy test) or lactation
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Previous treatment with Photodynamic Therapy (PDT) or thermal laser in study eye
- Anti-VEGF therapy within 6 weeks
- Intravitreal or subtenon's Kenalog within 6 months
- Intraocular surgery within 3 months or expected in the next 6 months
- Current or planned participation in other experimental treatments for wet AMD
- Other concurrent retinopathy or optic neuropathy
- Other causes of CNVM, i.e. myopic degeneration or ocular histoplasmosis (POHS)
- Significant media opacity precluding adequate view of the fundus for exam, photography or OCT
- History of radiation therapy to the head or study eye
- Diabetes mellitus or hemoglobin A1c \> 6
- Head tremor or h/o claustrophobia precluding positioning for proton irradiation
- Inability to maintain steady fixation with either eye
- History of Malignancy treated within 5 years
- Allergy to Fluorescein dye
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01213082
Start Date
September 1 2010
End Date
January 31 2017
Last Update
July 17 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis Eye Center
Sacramento, California, United States, 95817