Phase I/II Prospective, Randomized, Double-blinded Study of Intravitreal Anti-VEGF Therapy Combined With Proton Beam Radiation Versus Sham Irradiation in Treating Exudative Age-related Macular Degeneration
Overview
- Phase
- Phase 1
- Intervention
- 24GyE proton and Anti-VEGF
- Conditions
- Exudative Age-related Macular Degeneration
- Sponsor
- University of California, Davis
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Percent of Eyes With Severe Ocular Adverse
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 alone in eyes with exudative age-related macular degeneration.
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 intravitreal anti-VEGF therapy and epiretinal brachytherapy administered during vitrectomy surgery in treating eyes with exudative age-related macular degeneration (eAMD). In this study, we test the hypothesis that radiation to the macula administered noninvasively via proton beam is well-tolerated in eyes with eAMD when combined with intravitreal anti-VEGF therapy and that this combination therapy may act synergistically to result in sustained treatment effect in eyes with eAMD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
24GyE + anti-VEGF
Intervention: 24GyE proton and Anti-VEGF
16GyE + anti-VEGF
Intervention: 16GyE and anti-VEGF
Sham Irradiation + anti-VEGF
Intervention: Sham Irradiation and anti-VEGF
Outcomes
Primary Outcomes
Percent of Eyes With Severe Ocular Adverse
Time Frame: Month 24
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
Secondary Outcomes
- Number of Anti-VEGF Injections Administered(Month 24)