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

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Genentech, Inc.
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00517010
First received: August 15, 2007
Last updated: August 18, 2010
Last verified: August 2010
  Purpose

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. l


Condition Intervention Phase
Age-Related Macular Degeneration
Other: Proton beam irradiation and ranibizumab
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Incidence and severity of ocular adverse events, as identified by eye examination at 12 and 24 months will be determined. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. BCVA 2. Number of Ranibizumab injections 3. Number of eyes with loss of BCVA of > 15 Letters at 12 and 24 months [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: May 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517010

Sponsors and Collaborators
University of California, Davis
University of California, San Francisco
Genentech, Inc.
Investigators
Principal Investigator: Susanna S Park, MD PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Susanna S. Park, MD PhD/Associate Professor, University of California Davis
ClinicalTrials.gov Identifier: NCT00517010     History of Changes
Other Study ID Numbers: 200715285, FVF4150s
Study First Received: August 15, 2007
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, Davis:
Age-related macular degeneration
Exudative age-related macular degeneration
Wet macular degeneration
Intravitreal injection
Proton beam irradiation
Lucentis
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014