Proton Radiation Therapy for Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833325
• Other study ID #: UFPTI 1206-EY01
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: February 21, 2018
• Start date: May 2013
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Radiation:
• Proton radiation
Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (15)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Macfaul PA, Bedford MA. Ocular complications after therapeutic irradiation. Br J Ophthalmol. 1970 Apr;54(4):237-47. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with acute and late morbidity of the eye as a measure of safety		1 year after completion of radiation treatment
Primary	Number of participants with cessation of growth of neovascular membranes.		1 year after completion of radiation treatment
Primary	Visual acuity per comprehensive eye exam		1 year after completion of radiation treatment
Primary	Frequency of intravitreal injections following radiation treatment		1 year after completion of radiation treatment