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

Exudative Age-related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213082
• Other study ID #: 223071
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2010
• Est. completion date: January 31, 2017

Study information

• Verified date: May 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exudative Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	University of California Davis Eye Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Eyes With Severe Ocular Adverse	vision loss of 3 or more lines associated with radiation retinopathy or papillopathy	Month 24
Secondary	Number of Anti-VEGF Injections Administered	efficacy measure	Month 24