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
Primary Outcome Measures:
- Incidence and severity of ocular adverse events, as identified by eye examination at 12 and 24 months will be determined. [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 1. BCVA
2. Number of Ranibizumab injections
3. Number of eyes with loss of BCVA of > 15 Letters at 12 and 24 months [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: Yes ]
| Enrollment: |
5 |
| Study Start Date: |
May 2007 |
| Estimated Study Completion Date: |
December 2010 |
| Estimated Primary Completion Date: |
December 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
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.
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.
Purpose
