Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517010
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2007-08-15
Brief Title:
Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 100481 | OTHER | FDA IND | None |