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

This study is currently recruiting participants.
Verified July 2012 by University of California, Davis
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01213082
First received: September 29, 2010
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Number of eyes with 3 or more lines of vision loss from baseline [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: Yes ]
    Incidence of severe vision loss from radiation retinopathy or other causes


Secondary Outcome Measures:
  • number of anti-VEGF therapy [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: No ]
    efficacy measure

  • number of eyes with 3 or more lines of visual acuity gain from baseline [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: No ]
    Efficacy measure

  • Number of eyes with radiation retinopathy or papillopathy [ Time Frame: Month 12 and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213082

Contacts
Contact: Susanna S Park, MD PhD 916-734-6074 susanna.park@ucdmc.ucdavis.edu
Contact: Katrina Imson 916-734-6814 katrina.imson@ucdmc.ucdavis.edu

Locations
United States, California
University of California Davis Eye Center Recruiting
Sacramento, California, United States, 95817
Contact: Barbara Holderreed     916-734-6303     baholderreed@ucdavis.edu    
Contact: Debbie Oppenheim     916-734-6074        
Sub-Investigator: Lawrence S Morse, MD PhD            
Sub-Investigator: Alan Hunter, MD            
Sub-Investigator: Amar Patel, MD            
Mather VA Hospital Recruiting
Sacramento, California, United States
Contact: Allan Hunter, MD     916-734-6602     allan.hunter@ucdmc.ucdavis.edu    
Contact: Amar Patel, MD     916-734-6602     amar.patel@ucdmc.ucdavis.edu    
Sub-Investigator: Mohamid Ashrafzadah, MD            
Sub-Investigator: Allan Hunter, MD            
Sub-Investigator: Amar Patel, MD            
Sponsors and Collaborators
University of California, Davis
University of California, San Francisco
Investigators
Principal Investigator: Susanna S Park, MD PhD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01213082     History of Changes
Other Study ID Numbers: 201018281-1
Study First Received: September 29, 2010
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 18, 2013