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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Conditions
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Corneal Neovascularization

Intervention / Treatment
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* Drug: Dihematoporphyrin derivative
* Drug: prednisolone
* Procedure: Laser surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dihematoporphyrin derivative|nan|
|Drug: prednisolone|nan|
|Procedure: Laser surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular and respiratory diseases, corneal neovascularization, rare disease