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 (PBAMD2)

NCT01213082 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	University of California, Davis
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	34
Start date	2010-09
Completion	2017-01-31

Conditions

• Exudative Age-related Macular Degeneration

Interventions

• 24GyE proton and Anti-VEGF
• 16GyE and anti-VEGF
• Sham Irradiation and anti-VEGF

Primary outcomes

• Percent of Eyes With Severe Ocular Adverse — Month 24
  vision loss of 3 or more lines associated with radiation retinopathy or papillopathy

Countries

United States