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

NCT00517010 | Completed Early Phase 1 Results

• 2 other identifiers: 200715285100,481
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age-related Macular Degeneration

Keywords

Age-related macular degeneration; Exudative age-related macular degeneration; Wet macular degeneration; Intravitreal injection; Proton beam irradiation; Lucentis; Ranibizumab

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Ocular Adverse Events

  Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.

  24 months

Secondary Outcomes (1)

• 1. Change in BCVA From Baseline

  24 months

Study Arms (1)

proton beam with ranibizumab

EXPERIMENTAL

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.

Drug: Proton beam irradiation and ranibizumab

Interventions

Proton beam irradiation and ranibizumab 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.

Also known as: Lucentis and proton beam

proton beam with ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• University of California, San Francisco: collaborator
• Genentech, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 22183743 RESULT

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Susanna Park MD PhD
• Organization: University of California Davis

sscpark@ucdavis.edu

916-734-6074

Study Officials

• Susanna S Park, MD PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share