CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
24GyE proton and Anti-VEGF +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01213082
NCT01213082Phase 2Completed

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

University of California, Davis·interventional·Posted Oct 1, 2010·Updated Jul 17, 2018

In Brief

A Phase 2 clinical trial evaluating 24GyE proton and Anti-VEGF, 16GyE and anti-VEGF, and 1 other intervention for Exudative Age-related Macular Degeneration. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 1, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 15.8 years ago

Interventions

24GyE proton and Anti-VEGFdrug

24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy

16GyE and anti-VEGFdrug

16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy

Sham Irradiation and anti-VEGFdrug

2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy