CLINICAL TRIALS PROFILE FOR VERTEPORFIN

All Clinical Trials for verteporfin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00007969 ↗	Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma	Completed	QLT Inc.	Phase 1/Phase 2	2000-10-01	RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma. PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma.
NCT00002647 ↗	Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors	Unknown status	Medical College of Wisconsin	Phase 1	1994-05-01	RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.
NCT00049959 ↗	Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.	Terminated	Novartis	Phase 3	1969-12-31	The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.
NCT00049959 ↗	Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.	Terminated	QLT Inc.	Phase 3	1969-12-31	The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.

Clinical Trial Conditions for verteporfin

Condition Name

Condition Name for verteporfin
Intervention	Trials
Macular Degeneration	13
Age-Related Macular Degeneration	12
Choroidal Neovascularization	9
Polypoidal Choroidal Vasculopathy	6

Condition MeSH

Condition MeSH for verteporfin
Intervention	Trials
Macular Degeneration	40
Choroidal Neovascularization	21
Neovascularization, Pathologic	17
Wet Macular Degeneration	8

Clinical Trial Locations for verteporfin

Trials by Country

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Trials by Country for verteporfin
Location	Trials
United States	124
Japan	25
China	17
Canada	15
Korea, Republic of	13

Trials by US State

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Trials by US State for verteporfin
Location	Trials
California	9
Florida	8
Texas	8
Pennsylvania	7
Maryland	6

Clinical Trial Progress for verteporfin

Clinical Trial Phase

Clinical Trial Phase for verteporfin
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	11
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for verteporfin
Clinical Trial Phase	Trials
Completed	44
Unknown status	9
Terminated	8

Clinical Trial Sponsors for verteporfin

Sponsor Name

Sponsor Name for verteporfin
Sponsor	Trials
Novartis	10
QLT Inc.	7
Novartis Pharmaceuticals	6

Sponsor Type

Sponsor Type for verteporfin
Sponsor	Trials
Other	55
Industry	36
NIH	5

Verteporfin: Clinical Trials, Market Analysis, and Projections

Introduction to Verteporfin

Verteporfin, known by its brand name Visudyne, is a photosensitizing agent used in photodynamic therapy. It is primarily employed in the treatment of age-related macular degeneration (AMD) and other ocular conditions. Here, we will delve into the recent clinical trials, market analysis, and future projections for verteporfin.

Clinical Trials Update

Safety and Efficacy in Pancreatic Cancer

A recent phase 1 trial explored the use of verteporfin in photodynamic therapy for locally advanced pancreatic cancer. The trial involved 15 patients and found that the treatment was safe with few side effects. The procedure involved administering verteporfin followed by the application of a low-power red laser light to activate the drug and kill cancer cells. The trial reported mild to moderate abdominal pain in some patients, but overall, the treatment was well-tolerated. The average survival time for the patients was 15.5 months[1].

Long-Term Outcomes in AMD

In the context of AMD, two-year results from randomized clinical trials have shown that verteporfin therapy safely sustains visual acuity benefits for patients with predominantly classic choroidal neovascularization (CNV) subfoveal lesions. These trials, conducted across 22 ophthalmology practices in Europe and North America, demonstrated that verteporfin-treated patients had significantly better visual outcomes compared to those receiving a placebo. The benefits were sustained over the two-year follow-up period, highlighting the efficacy of verteporfin in managing AMD[4].

Market Analysis

Market Segmentation

The global verteporfin market is segmented based on indication, distribution channel, and region. The key indications include macular degeneration, pathological myopia, and ocular histoplasmosis. Distribution channels are categorized into hospital pharmacies, retail pharmacies, and online pharmacies. Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[2].

Market Dynamics

The verteporfin market is driven by several key factors, including the increasing prevalence of age-related macular degeneration, particularly in North America where around 11 million individuals are affected in the U.S. alone. Pharmaceutical companies are focusing on developing novel treatments and technologies, such as specialized lasers for photodynamic therapy, to address this growing need[5].

Competitive Landscape

Major players in the verteporfin market include Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., and Ciba Corporation. These companies are engaged in various strategies such as product development, mergers and acquisitions, and market expansion to increase their market share[2].

Market Projections

Growth Trends

The global verteporfin market is expected to grow significantly over the next few years. The market is anticipated to be driven by increasing demand for effective treatments for AMD and other ocular conditions. The market size is projected to expand due to advancements in photodynamic therapy and the development of new laser technologies specifically designed for verteporfin use[2].

Regional Insights

North America is expected to remain a major market for verteporfin due to the high prevalence of AMD in this region. Europe and Asia-Pacific are also anticipated to show significant growth, driven by increasing healthcare expenditure and the adoption of advanced medical technologies[5].

Market Size and Forecast

While specific figures for the verteporfin market are not provided, the broader context of the pharmaceutical and clinical trials market suggests robust growth. For instance, the global clinical trials market, which includes trials for drugs like verteporfin, is projected to grow from USD 91.50 billion in 2025 to USD 146.60 billion by 2033, at a CAGR of 6.07% during the forecast period[3].

Key Takeaways

• Clinical Trials: Verteporfin has shown safety and efficacy in phase 1 trials for pancreatic cancer and long-term benefits in AMD.
• Market Segmentation: The market is segmented by indication, distribution channel, and region.
• Market Dynamics: Driven by the increasing prevalence of AMD and advancements in photodynamic therapy.
• Competitive Landscape: Major players include Bausch Health Companies Inc., Cheplapharm Arzneimittel, and Novartis AG.
• Market Projections: Expected to grow significantly, particularly in North America, due to high demand for AMD treatments.

FAQs

What is verteporfin used for?

Verteporfin is primarily used in the treatment of age-related macular degeneration (AMD) and other ocular conditions through photodynamic therapy.

What were the findings of the phase 1 trial for pancreatic cancer?

The phase 1 trial found that verteporfin photodynamic therapy was safe with few side effects and resulted in an average survival time of 15.5 months for patients with locally advanced pancreatic cancer[1].

How effective is verteporfin in treating AMD?

Verteporfin therapy has been shown to safely sustain visual acuity benefits for up to two years in patients with predominantly classic CNV subfoveal lesions caused by AMD[4].

What are the key drivers of the verteporfin market?

The market is driven by the increasing prevalence of AMD, advancements in photodynamic therapy, and the development of new laser technologies.

Which regions are expected to show significant growth in the verteporfin market?

North America, Europe, and Asia-Pacific are anticipated to show significant growth due to high demand for AMD treatments and advancements in medical technologies[5].

Who are the major players in the verteporfin market?

Major players include Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., and Ciba Corporation[2].

Sources

1. Cancer Research UK: "A trial of verteporfin photodynamic therapy for locally advanced cancer of the pancreas."
2. OpenPR: "Navigating Verteporfin Market Trends: Growth Drivers and Regional Insights (2024-2031)."
3. Straits Research: "Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2033."
4. PubMed: "Two-year results of 2 randomized clinical trials—TAP report 2."
5. Coherent Market Insights: "Verteporfin Market Regional Analysis - Coherent Market Insights."