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

Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517010
• Other study ID #: 200715285
• Secondary ID: FVF4150s
• Status: Completed
• Phase: Phase 0
• First received: August 15, 2007
• Last updated: August 18, 2010
• Start date: May 2007
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. l

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Genentech, Inc., University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of ocular adverse events, as identified by eye examination at 12 and 24 months will be determined.		12 and 24 months	Yes
Secondary	1. BCVA 2. Number of Ranibizumab injections 3. Number of eyes with loss of BCVA of > 15 Letters at 12 and 24 months		12 months and 24 months	Yes