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

This study has been completed.
Sponsor:
Collaborator:
Eastern Virginia Medical School
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004430
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: August 2000

October 18, 1999
March 24, 2015
September 1994
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004430 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization
Not Provided

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.

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

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Treatment
Corneal Neovascularization
  • Drug: Dihematoporphyrin derivative
  • Drug: prednisolone
  • Procedure: Laser surgery
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 1998
Not Provided
  • Histologically proven corneal neovascularization (CNV): Must have at least 1 quadrant of significant CNV, which is due to bacterial, viral, parasitic, or fungal keratitis; alkaline acid or hydrocarbon chemical burns; ocular trauma and injury; severe ocular surface disease; or previous surgery with complications such as corneal allograft rejection are eligible
  • No concurrent systemic steroids
  • No concurrent immunosuppressive therapy
  • Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No rheumatoid arthritis; No congenital corneal scars; No active ocular infection or inflammation; No other active systemic collagen vascular disease; No uncontrolled glaucoma; No history of porphyrin allergies; Visual acuity of 20/400 or better in contralateral eye
Both
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004430
199/13380, EVMS-FDR001020
Not Provided
Not Provided
Not Provided
Not Provided
Medical College of Hampton Roads
Eastern Virginia Medical School
Study Chair: John D. Sheppard Eastern Virginia Medical School
FDA Office of Orphan Products Development
August 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP