Phase 2 N=34 Randomized Triple-blind Treatment

ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)

Exudative Age-related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT01213082 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Percent of Eyes With Severe Ocular Adverse — 0; 0; 0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 24GyE proton and Anti-VEGF (Drug); 16GyE and anti-VEGF (Drug); Sham Irradiation and anti-VEGF (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of California, Davis
Primary completion: Jan 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.