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

Sponsor:	University of California, Davis
Collaborators:	University of California, San Francisco Genentech
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00517010

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

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:

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

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

Sponsors and Collaborators

University of California, Davis

University of California, San Francisco

Genentech

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
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 12, 2012