Phase 2
Completed N=34
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
Exudative Age-related Macular Degeneration
Source: ClinicalTrials.gov NCT01213082 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Percent of Eyes With Severe Ocular Adverse — 0; 0; 0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Eyes With Severe Ocular Adverse |
0; 0; 0 | — |
| SECONDARY Number of Anti-VEGF Injections Administered |
4.67; 7.25; 9.67 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01213082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.