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

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

Age-Related Macular Degeneration

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

ChemIDplus related topics:

Ranibizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

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

Estimated Enrollment:	10
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009

Detailed Description:

Ten 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
Sampling Method:	Probability Sample

Study Population

Patients seen or referred to the Retina Service for newly diagnosed exudative age-related macular degeneration

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

Contacts


Contact: Barbara Holderreed	(916) 734-6303	baholderreed@ucdavis.edu

Locations


United States, California
	Department of Ophthalmology & Vision Science, University of California Davis	Recruiting
	Sacramento, California, United States, 95817
	Contact: Barbara Holderreed 916-734-6303 baholderreed@ucdavis.edu

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

Responsible Party:	University of California Davis ( Susanna S. Park, MD PhD/Associate Professor )
Study ID Numbers:	200715285, FVF4150s
First Received:	August 15, 2007
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00517010
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

Study placed in the following topic categories:

Eye Diseases

Retinal Degeneration

Macular Degeneration

Retinal Diseases

Retinal degeneration

ClinicalTrials.gov processed this record on October 07, 2008

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