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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01213082
Recruitment Status : Completed
First Posted : October 1, 2010
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 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
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percent of Eyes With Severe Ocular Adverse [ Time Frame: Month 24 ]
    vision loss of 3 or more lines associated with radiation retinopathy or papillopathy


Secondary Outcome Measures :
  1. Number of Anti-VEGF Injections Administered [ Time Frame: Month 24 ]
    efficacy measure


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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
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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


Locations
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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
Investigators
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Principal Investigator: Susanna S Park, MD PhD University of California, Davis
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Study Protocol and Statistical Analysis Plan  [PDF] September 8, 2010

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01213082    
Other Study ID Numbers: 223071
First Posted: October 1, 2010    Key Record Dates
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018
Last Verified: May 2018
Keywords provided by University of California, Davis:
Exudative Age-related Macular Degeneration
Proton beam irradiation
ranibizumab
bevacizumab
anti-VEGF therapy
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors