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

NCT ID: NCT01213082

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-01-31

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.

Conditions

Exudative Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

24GyE + anti-VEGF

Group Type: EXPERIMENTAL

24GyE proton and Anti-VEGF

Intervention Type: DRUG

24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy

16GyE + anti-VEGF

Group Type: EXPERIMENTAL

16GyE and anti-VEGF

Intervention Type: DRUG

16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy

Sham Irradiation + anti-VEGF

Group Type: SHAM_COMPARATOR

Sham Irradiation and anti-VEGF

Intervention Type: DRUG

2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

24Gy Proton Beam + Anti-VEGF; 16Gy proton beam + Anti-VEGF; Sham proton beam + anti-VEGF

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanna S Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Eye Center

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32844399 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

223071

Identifier Type: -

Identifier Source: org_study_id