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

Phase 1

Completed

• Conditions: Exudative Age-related Macular Degeneration
• Interventions: Drug: 16GyE and anti-VEGF; Drug: Sham Irradiation and anti-VEGF; Drug: 24GyE proton and Anti-VEGF

• Registration Number: NCT01213082
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Status Verified: 2018-05
• Results First Submitted: 2018-05-07
• Results First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Results First Posted: 2018-07-17
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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
  • Submacular fibrosis less than 25% of total lesion
  • Candidate for intravitreal anti-VEGF therapy

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
  • Other concurrent retinopathy or optic neuropathy
  • Other causes of CNVM, i.e. myopic degeneration or ocular histoplasmosis (POHS)
  • Significant media opacity precluding adequate view of the fundus for exam, photography or OCT
  • History of radiation therapy to the head or study eye
  • Diabetes mellitus or hemoglobin A1c > 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
16GyE + anti-VEGF	16GyE and anti-VEGF	-
Sham Irradiation + anti-VEGF	Sham Irradiation and anti-VEGF	-
24GyE + anti-VEGF	24GyE proton and Anti-VEGF	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Anti-VEGF Injections Administered	Month 24	efficacy measure

Trial Locations

Locations (1)

University of California Davis Eye Center; 🇺🇸 Sacramento, California, United States