Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517010
Recruitment Status : Completed
First Posted : August 16, 2007
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
University of California, San Francisco
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis

August 15, 2007
August 16, 2007
December 2, 2015
July 11, 2016
July 11, 2016
May 2007
June 2010   (Final data collection date for primary outcome measure)
Incidence and Severity of Ocular Adverse Events [ Time Frame: 24 months ]
Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.
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Complete list of historical versions of study NCT00517010 on Archive Site
1. Change in BCVA From Baseline [ Time Frame: 24 months ]
change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline
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Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration
Phase 1 Pilot Open Label Prospective Observational Study of Safety and Tolerability of Lucentis Combined With Proton Beam Irradiation in Treating Exudative Age-related Macular Degeneration
Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of vascular endothelial growth factor which was recently FDA approved for treatment of wet macular degeneration. It appears to be the most effective therapy thus far for wet macular degeneration among all drugs FDA approved for this condition. If no major safety issues are associated with this combination therapy, a larger study will be conducted to determine whether this combination therapy is more effective than Lucentis monotherapy.
Five subjects diagnosed with wet macular degeneration will be treated with standard of care, i.e. intravitreal Lucentis injection monthly for the first four months and as needed thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated with 24 Gy of proton beam divided into two fractions. Each subject will be followed for 2 yrs with monthly examination.
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Age-related Macular Degeneration
Drug: Proton beam irradiation and ranibizumab
ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
Other Name: Lucentis and proton beam
Experimental: proton beam with ranibizumab
Intervention is 24Gy proton radiation in 2 fractions given within 6 weeks of first dose of intravitreal ranibizumab (0.5mg) drug combined with four monthly doses of intravitreal lucentis and monthly prn lucentis thereafter.
Intervention: Drug: Proton beam irradiation and ranibizumab
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • Hgb A1C < 6
  • Diagnosed with Age-related Macular Degeneration (ARMD) with active subfoveal choroidal neovascular membrane (CNVM), new or recurrent
  • Visual acuity 20/60 to 20/400
  • Lesion size < 12 Disc Area
  • Submacular hemorrhage less than 75% of total lesion
  • Submacular fibrosis less than 25% of total lesion
  • Candidate for intravitreal Lucentis

Exclusion Criteria:

  • 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
  • CNVM within 1 mm from the disc margin
  • Photodynamic Therapy (PDT) within 3 months
  • 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
  • Systemic anticoagulation with coumadin
  • Head tremor or h/o claustrophobia precluding positioning for proton irradiation
  • Inability to maintain steady fixation with either eye
  • Diabetes mellitus requiring treatment
  • History of Malignancy treated within 5 years
  • Allergy to Fluorescein dye
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
100,481 ( Other Identifier: FDA IND )
Not Provided
Plan to Share IPD: Yes
Plan Description: Findings have been presented at national and international venues and published in scientific peer-reviewed journal
University of California, Davis
University of California, Davis
  • University of California, San Francisco
  • Genentech, Inc.
Principal Investigator: Susanna S Park, MD PhD University of California, Davis
University of California, Davis
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP