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

Primary Purpose

Exudative Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
24GyE proton and Anti-VEGF
16GyE and anti-VEGF
Sham Irradiation and anti-VEGF
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-related Macular Degeneration focused on measuring Exudative Age-related Macular Degeneration, Proton beam irradiation, ranibizumab, bevacizumab, anti-VEGF therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

24GyE + anti-VEGF

16GyE + anti-VEGF

Sham Irradiation + anti-VEGF

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Anti-VEGF Injections Administered
efficacy measure

Full Information

First Posted
September 29, 2010
Last Updated
June 19, 2018
Sponsor
University of California, Davis
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01213082
Brief Title
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
Acronym
PBAMD2
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-related Macular Degeneration
Keywords
Exudative Age-related Macular Degeneration, Proton beam irradiation, ranibizumab, bevacizumab, anti-VEGF therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24GyE + anti-VEGF
Arm Type
Experimental
Arm Title
16GyE + anti-VEGF
Arm Type
Experimental
Arm Title
Sham Irradiation + anti-VEGF
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
24GyE proton and Anti-VEGF
Other Intervention Name(s)
24Gy Proton Beam + Anti-VEGF
Intervention Description
24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Intervention Type
Drug
Intervention Name(s)
16GyE and anti-VEGF
Other Intervention Name(s)
16Gy proton beam + Anti-VEGF
Intervention Description
16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
Intervention Type
Drug
Intervention Name(s)
Sham Irradiation and anti-VEGF
Other Intervention Name(s)
Sham proton beam + anti-VEGF
Intervention Description
2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
Primary Outcome Measure Information:
Title
Percent of Eyes With Severe Ocular Adverse
Description
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
Time Frame
Month 24
Secondary Outcome Measure Information:
Title
Number of Anti-VEGF Injections Administered
Description
efficacy measure
Time Frame
Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna S Park, MD PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Eye Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32844399
Citation
Evans JR, Igwe C, Jackson TL, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD004004. doi: 10.1002/14651858.CD004004.pub4.
Results Reference
derived

Learn more about this trial

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

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