Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization
Recruitment status was Recruiting
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.
Drug: Dihematoporphyrin derivative
Procedure: Laser surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||October 1999|
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.
|United States, Virginia|
|Eastern Virginia Medical School||Recruiting|
|Norfolk, Virginia, United States, 23507|
|Contact: John D. Sheppard 757-622-2200|
|Study Chair:||John D. Sheppard||Eastern Virginia Medical School|