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Proton Radiation Therapy for Macular Degeneration

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age-Related Macular Degeneration

Intervention: Proton radiation (Radiation)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Roi Dagan, MD,, Principal Investigator, Affiliation: University of Florida Proton Therapy Institute

Overall contact:
Intake Coordinator, Phone: 877-686-6009

Summary

This is a pilot study to determine if proton radiation therapy can provide effective and safe treatment for subfoveal neovascularization membrane (SNVM). The study will include adult patients over the age of 50 with macular degeneration, who have subfoveal neovascularization membrane (SNVM) and have had prior treatment with Avastin or Lucentis. Additional purposes of this study are to see if the growth of neovascular membranes can be stopped and overall vision improved with the use of protons and assess the side effects associated with this treatment.

Clinical Details

Official title: A Pilot Study to Assess the Safety of Proton Therapy for Subfoveal Neovascularization Associated With Age-Related Macular Degeneration

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of participants with acute and late morbidity of the eye as a measure of safety

Number of participants with cessation of growth of neovascular membranes.

Visual acuity per comprehensive eye exam

Frequency of intravitreal injections following radiation treatment

Detailed description: As part of this study, participants will have had a standard of care comprehensive eye exam by an Ophthalmologist to include visual acuity, fundus photography, fluorescein angiography and optical coherence tomography prior to treatment. Participants will receive radiation using protons for 2 consecutive days. Each treatment will take 30 minutes. They will receive a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments. A total of 10 participants will be enrolled on this study. A comprehensive eye exam by an Ophthalmologist will be performed 30 days after radiation treatment with protons. Additionally, a physical examination per a Radiation Oncologist including a toxicity evaluation and comprehensive eye exam by an Ophthalmologist will be performed every 3 months for 1 year following radiation treatment.

Eligibility

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

Criteria:

Inclusion Criteria:

- Patients with subfoveal neovascular membranes identified on fluorescein angiography.

- Visual acuity (best corrected vision) 20/200 or worse in affected eye.

- Patient must be 50 years of age or older at time of consent.

- Patients must have had prior treatment for macular degeneration with Avastin

(bevacizumab) or Lucentis (ranibizumab).

- Women must be post menopausal or have had a hysterectomy.

Exclusion Criteria:

- History of diabetes.

Locations and Contacts

Intake Coordinator, Phone: 877-686-6009

University of Florida Proton Therapy Institute, Jacksonville, Florida 32206, United States; Recruiting
Intake Coordinator, Phone: 877-686-6009
Roi Dagan, MD, Principal Investigator
Additional Information

Related publications:

Macular Degeneration Foundation Adult Macular Degeneration. Available at: http://www.eyesight.org/Macular_Degeneration/Adult_MD/adult_md.html. Accessed March 8, 2012.

Argon laser photocoagulation for senile macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol. 1982 Jun;100(6):912-8.

Krypton laser photocoagulation for neovascular lesions of age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1990 Jun;108(6):816-24.

Bressler NM; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two-year results of 2 randomized clinical trials-tap report 2. Arch Ophthalmol. 2001 Feb;119(2):198-207.

Laser photocoagulation of subfoveal neovascular lesions in age-related macular degeneration. Results of a randomized clinical trial. Macular Photocoagulation Study Group. Arch Ophthalmol. 1991 Sep;109(9):1220-31.

Chakravarthy U, Gardiner TA, Archer DB, Maguire CJ. A light microscopic and autoradiographic study of non-irradiated and irradiated ocular wounds. Curr Eye Res. 1989 Apr;8(4):337-48.

Plowman PN, Harnett AN. Radiotherapy in benign orbital disease. I: Complicated ocular angiomas. Br J Ophthalmol. 1988 Apr;72(4):286-8.

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Guyer DR, Mukai S, Egan KM, Seddon JM, Walsh SM, Gragoudas ES. Radiation maculopathy after proton beam irradiation for choroidal melanoma. Ophthalmology. 1992 Aug;99(8):1278-85.

Chakravarthy U, Houston RF, Archer DB. Treatment of age-related subfoveal neovascular membranes by teletherapy: a pilot study. Br J Ophthalmol. 1993 May;77(5):265-73.

Yonemoto LT, Slater JD, Blacharski P, Archambeau JO, Loredo LN, Oeinck SC, Teichman S, Moyers M, Slater JM. Dose Response in the Treatment of Subfoveal Choroidal Neovascularization in Age-Related Macular Degeneration: Results of a Phase I/II Dose-Escalation Study Using Proton Radiotherapy. Journal of Radiosurgery. 2000;3(1):47-54. DOI: 10.1023/A:1009525220716

Zambarakji HJ, Lane AM, Ezra E, Gauthier D, Goitein M, Adams JA, Munzenrider JE, Miller JW, Gragoudas ES. Proton beam irradiation for neovascular age-related macular degeneration. Ophthalmology. 2006 Nov;113(11):2012-9. Epub 2006 Aug 28.

Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44.

Sivagnanavel V, Evans JR, Ockrim Z, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004004. Review. Update in: Cochrane Database Syst Rev. 2010;(5):CD004004.

Park SS, Daftari I, Phillips T, Morse LS. Three-year follow-up of a pilot study of ranibizumab combined with proton beam irradiation as treatment for exudative age-related macular degeneration. Retina. 2012 May;32(5):956-66. doi: 10.1097/IAE.0b013e31822a8d6a.

Starting date: May 2013
Last updated: June 16, 2015

Page last updated: August 23, 2015

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