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
|First Submitted Date ICMJE||October 18, 1999|
|First Posted Date ICMJE||October 19, 1999|
|Last Update Posted Date||March 25, 2015|
|Study Start Date ICMJE||September 1994|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00004430 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization|
|Official Title ICMJE||Not Provided|
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.
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 ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Condition ICMJE||Corneal Neovascularization|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||September 1998|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||12 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00004430|
|Other Study ID Numbers ICMJE||199/13380
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Medical College of Hampton Roads|
|Collaborators ICMJE||Eastern Virginia Medical School|
|PRS Account||FDA Office of Orphan Products Development|
|Verification Date||August 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP