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

NCT ID: NCT00517010

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-06-30

Brief Summary

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.

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.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Proton beam irradiation and ranibizumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lucentis and proton beam

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanna S Park, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

References

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.

Reference Type: RESULT

PMID: 22183743 (View on PubMed)

Other Identifiers

100,481

Identifier Type: OTHER

Identifier Source: secondary_id

200715285

Identifier Type: -

Identifier Source: org_study_id