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

NCT01213082 | Completed Phase 1 Results

• 1 other identifier: 223071
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Exudative Age-related Macular Degeneration

Keywords

Exudative Age-related Macular Degeneration; Proton beam irradiation; ranibizumab; bevacizumab; anti-VEGF therapy

Outcome Measures

Primary Outcomes (1)

• Percent of Eyes With Severe Ocular Adverse

  vision loss of 3 or more lines associated with radiation retinopathy or papillopathy

  Month 24

Secondary Outcomes (1)

• Number of Anti-VEGF Injections Administered

  Month 24

Study Arms (3)

24GyE + anti-VEGF

EXPERIMENTAL

Drug: 24GyE proton and Anti-VEGF

16GyE + anti-VEGF

EXPERIMENTAL

Drug: 16GyE and anti-VEGF

Sham Irradiation + anti-VEGF

SHAM COMPARATOR

Drug: Sham Irradiation and anti-VEGF

Interventions

24GyE proton and Anti-VEGF DRUG

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

Also known as: 24Gy Proton Beam + Anti-VEGF

24GyE + anti-VEGF

16GyE and anti-VEGF DRUG

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

Also known as: 16Gy proton beam + Anti-VEGF

16GyE + anti-VEGF

Sham Irradiation and anti-VEGF DRUG

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

Also known as: Sham proton beam + anti-VEGF

Sham Irradiation + anti-VEGF

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California Davis Eye Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• 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.

  PMID: 32844399 DERIVED

Results Point of Contact

• Title: Susanna Park, MD
• Organization: University of California Davis

sscpark@ucdavis.edu

9167346074

Study Officials

• Susanna S Park, MD PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 1, 2010
• Study Start: September 1, 2010
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-05

Locations

US (1)