Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004430
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization
Sponsor:
Medical College of Hampton Roads
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-08
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:
OBJECTIVES
I Demonstrate the safety and efficacy of dihematoporphyrin derivative DHP in laser photodynamic therapy PDT in patients with corneal neovascularization
II Document the histopathologic mechanism of action in selected patients undergoing penetrating keratoplasty following PDT therapy for corneal neovascularization
III Facilitate FDA product approval of DHP as a photosensitizing agent for laser treatment in these patients
IV Explore the use of this photosensitizer for ocular and cutaneous basal cell and squamous cell carcinoma
I Demonstrate the safety and efficacy of dihematoporphyrin derivative DHP in laser photodynamic therapy PDT in patients with corneal neovascularization
II Document the histopathologic mechanism of action in selected patients undergoing penetrating keratoplasty following PDT therapy for corneal neovascularization
III Facilitate FDA product approval of DHP as a photosensitizing agent for laser treatment in these patients
IV Explore the use of this photosensitizer for ocular and cutaneous basal cell and squamous cell carcinoma
Detailed Description:
PROTOCOL OUTLINE
This is a randomized placebo controlled study
Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive topical dihematoporphyrin derivative DHP every 3 hours on days -3 and -2 Patients undergo laser surgery on day 0 After photodynamic PDT therapy patients receive topical prednisolone phosphate four times a day for 90 days Ninety days following PDT patients may undergo corneal transplantation
Arm II Patients receive placebo topical gel and undergo sham laser surgery following arm I schedule then receive topical prednisolone phosphate four times a day for 90 days Patients may be crossed over to arm I if disease progression is observed
Arm III Patients receive a compressed 1 day schedule of DHP with 5 doses in the morning and then undergo laser surgery in the evening
Patients are assessed on days 1 7 30 and 90 after PDT therapy
Completion date provided represents the completion date of the grant per OOPD records
This is a randomized placebo controlled study
Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive topical dihematoporphyrin derivative DHP every 3 hours on days -3 and -2 Patients undergo laser surgery on day 0 After photodynamic PDT therapy patients receive topical prednisolone phosphate four times a day for 90 days Ninety days following PDT patients may undergo corneal transplantation
Arm II Patients receive placebo topical gel and undergo sham laser surgery following arm I schedule then receive topical prednisolone phosphate four times a day for 90 days Patients may be crossed over to arm I if disease progression is observed
Arm III Patients receive a compressed 1 day schedule of DHP with 5 doses in the morning and then undergo laser surgery in the evening
Patients are assessed on days 1 7 30 and 90 after PDT therapy
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EVMS-FDR001020 | None | None | None |