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

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Proton beam irradiation and ranibizumab

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Age-related macular degeneration, Exudative age-related macular degeneration, Wet macular degeneration, Intravitreal injection, Proton beam irradiation, Lucentis, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

proton beam with ranibizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

1. Change in BCVA From Baseline

change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline

Full Information

NCT ID

NCT00517010

First Posted

August 15, 2007

Last Updated

June 28, 2016

Sponsor

University of California, Davis

Collaborators

University of California, San Francisco, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00517010

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

University of California, San Francisco, Genentech, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

proton beam with ranibizumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Proton beam irradiation and ranibizumab

Other Intervention Name(s)

Lucentis and proton beam

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence and Severity of Ocular Adverse Events

Description

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.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

1. Change in BCVA From Baseline

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanna S Park, MD PhD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Findings have been presented at national and international venues and published in scientific peer-reviewed journal

Citations:

PubMed Identifier

22183743

Citation

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.

Results Reference

result

Available IPD and Supporting Information:

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

http://ovidsp.tx.ovid.com/sp-3.20.0b/ovidweb.cgi?QS2=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

Available IPD/Information Comments

Published data

Learn more about this trial

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

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