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CLINICAL TRIALS PROFILE FOR VISUDYNE

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00021736	Phase II/III Study of Anti-VEGF in Neovascular AMD	Completed	Eyetech Pharmaceuticals	Phase 2/Phase 3	2001-07-01	The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD
NCT00041483	Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD	Completed	Alcon Research	Phase 3	2002-06-01	The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.
NCT00043680	Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy	Completed	National Eye Institute (NEI)	Phase 2	2002-08-01	This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can help stabilize or improve vision in patients with age-related macular degeneration (AMD) who are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina-that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss. However, the treatment usually does not cause vision to improve, and it has only a temporary effect, requiring several treatments over 2 years. Furthermore, PDT does not work in all patients and may actually cause some swelling and re-growth of blood vessels. Celecoxib is an anti-inflammatory drug that, in animal studies, has prevented the growth of abnormal blood vessels associated with tumors and with injury to the cornea. Thus, the drug might reduce swelling and prevent vessel re-growth in AMD, enhancing the effectiveness of PDT. Patients 55 years of age and older with AMD and visual acuity of 20/20 to 20/200 may be eligible for this study. Participants will be randomly assigned to take either celecoxib or a placebo (a look-alike pill with no active drug) twice a day and undergo the various tests and procedures detailed below. Not every examination will be done at every visit, but all may be required at one visit. - Medical history and physical examination - Blood drawing: A blood sample is drawn from an arm vein to evaluate liver and kidney function - Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined - Photography: Photographs of the eye are taken using a special camera with a bright flash - Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. The retina is photographed using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography: This procedure, similar to fluorescein angiography, uses a green dye to photograph the retina and identify portions of abnormal vessels in the deepest part of the retina. - Optical coherence tomography: This new technique uses light to produce a 2-dimensional cross-sectional picture of the retina. The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights, first with one eye and then the other. One week after starting the study medications, laser treatment will begin. For this procedure, a needle is placed in an arm vein and a chemical called verteporfin (Visudyne® (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds. Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations and possible re-treatment, if needed. Some patients will be asked to return 1 to 2 weeks after the first PDT for an eye examination and fluorescein angiography.
NCT00056823	Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)	Completed	Genentech, Inc.	Phase 1/Phase 2	2003-03-01	The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.
NCT00061594	A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration	Completed	Genentech, Inc.	Phase 3	2003-05-01	This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.
NCT00100009	Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration	Completed	National Eye Institute (NEI)	Phase 3	2004-12-01	This study will test the safety and effectiveness of combining a laser treatment called photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone acetonide for treating age-related macular degeneration (AMD). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal blood vessels behind the retina that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss; however, it has only a temporary effect and does not work in all patients. Furthermore, it may actually cause some swelling and re-growth of blood vessels. Triamcinolone acetonide can help lessen swelling and scarring. Patients 50 years of age and older with AMD may be eligible for this study. Candidates are screened with a medical history, medical evaluation, and eye examinations (see below). Participants are randomly assigned to one of three treatment groups: 1) PDT plus 1 mg TAC-PF; 2) PDT plus 4 mg TAC-PF; or 3) PDT plus sham injection (a syringe with no needle is pressed against the eye). Treatments are given the day the patient enrolls in the study and then every 3 months for 2 years, as long as the therapy is thought beneficial. Patients who must discontinue TAC-PF injections may still be treated with PDT if medically necessary. In addition to treatment, patients undergo the following tests and procedures: - Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined. - Fundus photography: Photographs of the back of the eye are taken using a special camera with a bright flash. - Lens photography: Photographs of the lens are taken to look for development of cataracts. - Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. The retina is photographed using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Optical coherence tomography: This test uses light to produce a 2-dimensional cross-sectional picture of the retina. The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights, first with one eye and then the other. - PDT: A needle is placed in an arm vein and a drug called verteporfin (Visudyne® (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds. - TAC-PF or injections (for those in the TAC-PF treatment groups): Numbing and anesthetic drops are placed on the surface of the eye before injection of TAC-PF. Another anesthetic is then applied to the lower part of the eye with a cotton swab. After a few minutes, TAC-PF is injected into the vitreous (jelly-like substance inside the eye). Patients receiving sham injections undergo the identical procedure, except a syringe with no needle is pressed against the eye to seem like a real injection. All patients receive antibiotic drops to put in their eye for 2 days after each treatment. Patients return to the clinic anytime from 2 to 7 days after each treatment for a check of vision, eye pressure, and treatment side effects. Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first treatment.
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