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

Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exudative Age-related Macular Degeneration

Intervention: 24GyE proton and Anti-VEGF (Drug); 16GyE and anti-VEGF (Drug); Sham Irradiation and anti-VEGF (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of California, Davis

Official(s) and/or principal investigator(s):
Susanna S Park, MD PhD, Principal Investigator, Affiliation: University of California, Davis

Overall contact:
Susanna S Park, MD PhD, Phone: 916-734-6074, Email: susanna.park@ucdmc.ucdavis.edu

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of eyes with 3 or more lines of vision loss from baseline

Secondary outcome:

number of anti-VEGF therapy

number of eyes with 3 or more lines of visual acuity gain from baseline

Number of eyes with radiation retinopathy or papillopathy

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Susanna S Park, MD PhD, Phone: 916-734-6074, Email: susanna.park@ucdmc.ucdavis.edu

University of California Davis Eye Center, Sacramento, California 95817, United States; Recruiting
Barbara Holderreed, Phone: 916-734-6303, Email: baholderreed@ucdavis.edu
Katrina Imson, Phone: 916-734-6602
Lawrence S Morse, MD PhD, Sub-Investigator
Ala Moshiri, MD, Sub-Investigator
Additional Information

Starting date: September 2010
Last updated: December 1, 2014

Page last updated: August 20, 2015

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