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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


Phase 0
50 Years
N/A
Not Enrolling
Both
Age-Related Macular Degeneration

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence and severity of ocular adverse events, as identified by eye examination at 12 and 24 months will be determined.

Outcome Time Frame:

12 and 24 months

Safety Issue:

Yes

Principal Investigator

Susanna S Park, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Food and Drug Administration

Study ID:

200715285

NCT ID:

NCT00517010

Start Date:

May 2007

Completion Date:

June 2010

Related Keywords:

  • Age-Related Macular Degeneration
  • Age-related macular degeneration
  • Exudative age-related macular degeneration
  • Wet macular degeneration
  • Intravitreal injection
  • Proton beam irradiation
  • Lucentis
  • Ranibizumab
  • Macular Degeneration
  • Wet Macular Degeneration

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