NCT01833325

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

4.8 years

First QC Date

March 27, 2013

Last Update Submit

February 21, 2018

Conditions

Age-Related Macular Degeneration

Keywords

Age-Related Macular DegenerationMacular DegenerationProton radiationChoroidal Neovascular Membranes

Outcome Measures

Primary Outcomes (4)

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

    1 year after completion of radiation treatment

  • Number of participants with cessation of growth of neovascular membranes.

    1 year after completion of radiation treatment

  • Visual acuity per comprehensive eye exam

    1 year after completion of radiation treatment

  • Frequency of intravitreal injections following radiation treatment

    1 year after completion of radiation treatment

Study Arms (1)

Proton radiation

EXPERIMENTAL

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

Radiation: Proton radiation

Interventions

Proton radiationRADIATION

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

Proton radiation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location

Related Publications (16)

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

    BACKGROUND

  • Argon laser photocoagulation for senile macular degeneration. Results of a randomized clinical trial. Arch Ophthalmol. 1982 Jun;100(6):912-8. doi: 10.1001/archopht.1982.01030030920003.

    PMID: 7046707BACKGROUND

  • 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. doi: 10.1001/archopht.1990.01070080058036.

    PMID: 1693496BACKGROUND

  • 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.

    PMID: 11176980BACKGROUND

  • 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. doi: 10.1001/archopht.1991.01080090044025.

    PMID: 1718250BACKGROUND

  • 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. doi: 10.3109/02713688908996381.

    PMID: 2721224BACKGROUND

  • Plowman PN, Harnett AN. Radiotherapy in benign orbital disease. I: Complicated ocular angiomas. Br J Ophthalmol. 1988 Apr;72(4):286-8. doi: 10.1136/bjo.72.4.286.

    PMID: 3378026BACKGROUND

  • Macfaul PA, Bedford MA. Ocular complications after therapeutic irradiation. Br J Ophthalmol. 1970 Apr;54(4):237-47. doi: 10.1136/bjo.54.4.237. No abstract available.

    PMID: 5310660BACKGROUND

  • 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. doi: 10.1016/s0161-6420(92)31832-9.

    PMID: 1325044BACKGROUND

  • 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. doi: 10.1136/bjo.77.5.265.

    PMID: 8318462BACKGROUND

  • 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

    BACKGROUND

  • 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. doi: 10.1016/j.ophtha.2006.05.036. Epub 2006 Aug 28.

    PMID: 16935343BACKGROUND

  • 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. doi: 10.1056/NEJMoa062655.

    PMID: 17021319BACKGROUND

  • Sivagnanavel V, Evans JR, Ockrim Z, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004004. doi: 10.1002/14651858.CD004004.pub2.

    PMID: 15495075BACKGROUND

  • 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.

    PMID: 22183743BACKGROUND

  • 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: 32844399DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Roi Dagan, MD,

    University of Florida Proton Therapy Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 16, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

US(1)