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Trial record 2 of 18 for:    eye proton

ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD) (PBAMD2)

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ClinicalTrials.gov Identifier: NCT01213082
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: 24GyE proton and Anti-VEGF Drug: 16GyE and anti-VEGF Drug: Sham Irradiation and anti-VEGF Phase 1 Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2010
Primary Completion Date : January 31, 2017
Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 24GyE + anti-VEGF Drug: 24GyE proton and Anti-VEGF
24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Other Name: 24Gy Proton Beam + Anti-VEGF
Experimental: 16GyE + anti-VEGF Drug: 16GyE and anti-VEGF
16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Other Name: 16Gy proton beam + Anti-VEGF
Sham Comparator: Sham Irradiation + anti-VEGF Drug: Sham Irradiation and anti-VEGF
2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
Other Name: Sham proton beam + anti-VEGF

Outcome Measures

Primary Outcome Measures :
  1. Number of eyes with 3 or more lines of vision loss from baseline [ Time Frame: Month 12 and 24 ]
    Incidence of severe vision loss from radiation retinopathy or other causes

Secondary Outcome Measures :
  1. number of anti-VEGF therapy [ Time Frame: Month 12 and 24 ]
    efficacy measure

  2. number of eyes with 3 or more lines of visual acuity gain from baseline [ Time Frame: Month 12 and 24 ]
    Efficacy measure

  3. Number of eyes with radiation retinopathy or papillopathy [ Time Frame: Month 12 and 24 ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213082

United States, California
University of California Davis Eye Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
University of California, San Francisco
Principal Investigator: Susanna S Park, MD PhD University of California, Davis
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01213082     History of Changes
Other Study ID Numbers: 201018281
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017

Keywords provided by University of California, Davis:
Exudative Age-related Macular Degeneration
Proton beam irradiation
anti-VEGF therapy

Additional relevant MeSH terms:
Eye Diseases
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents