Randomized Study of Photodynamic Therapy Using Dihematoporphyrin in Patients With Corneal Neovascularization
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Ocular |
| Therapuetic Areas: | Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/16/2015 |
| Start Date: | October 1999 |
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.
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.
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.
- 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
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