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Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization

This study is currently recruiting patients.

Sponsored by: FDA Office of Orphan Products Development
Eastern Virginia Medical School
Information provided by: FDA Office of Orphan Products Development

Purpose

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.

Condition Treatment or Intervention
Corneal Neovascularization
 Drug: Dihematoporphyrin derivative
 Drug: prednisolone
 Procedure: Laser surgery

MedlinePlus related topics:  Eye Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control

Further Study Details: 

Expected Total Enrollment:  150

Study start: October 1999

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.

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria


Location and Contact Information


Virginia
      Eastern Virginia Medical School, Norfolk,  Virginia,  23507,  United States; Recruiting
John D. Sheppard  757-622-2200 

Study chairs or principal investigators

John D. Sheppard,  Study Chair,  Eastern Virginia Medical School   

More Information

Publications

Sheppard JD, Chames MA, Clarke KC, et al.: Argon laser photodynamic thrombosis of human corneal neovascularization utilizing intravenous dihematoporphyrin. Investigative Ophthalmology and Visual Science 35(4): 1350, 1994.

Chames MA, Sheppard JD, Mittal DC, et al.: A rabbit model for argon laser photodynamic therapy of corneal neovascularization utilizing topical dihematoporphyrin. Investigative Ophthalmology and Visual Science 36(1): 146, 1995.

Mittal DC, Chames MS, Sheppard JD, et al.: Distribution of dihematoporphyrin in rabbit cornea, iris, aqueous humor and plasma after topical intravenous administration. Investigative Ophthalmology and Visual Science 36(13): 2564, 1995.

Lattanzio F, Rusch A, Sheppard J, et al.: Documentation of corneal neovascularization by quantitative video fluorescein angiography. Investigative Ophthalmology and Visual Science 37: S546, 1996.

Cox KW, Sheppard JD, Lattanzio FA, et al.: Photodynamic therapy of corneal neovascularization using topical dihematoporphyrin ester. Investigative Ophthalmology and Visual Science 38: S512, 1997.

Williams PB, Sheppard JD, Chames MA, et al.: Distribution of dihematoporphyrin in rabbit cornea, iris, aqueous humor and serum after topical vs intravenous administration. Journal of Clinical Pharmacology 35(10): 936, 1995.

Study ID Numbers:  199/13380; EVMS-FDR001020
Record last reviewed:  August 2000
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004430
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09
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