Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization
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|ClinicalTrials.gov Identifier: NCT00004430|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Corneal Neovascularization||Drug: Dihematoporphyrin derivative Drug: prednisolone Procedure: Laser surgery||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Study Start Date :||September 1994|
|Study Completion Date :||September 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004430
|United States, Virginia|
|Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23507|
|Study Chair:||John D. Sheppard||Eastern Virginia Medical School|