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Last Updated: March 31, 2025

CLINICAL TRIALS PROFILE FOR FLUORESCEIN SODIUM


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505(b)(2) Clinical Trials for FLUORESCEIN SODIUM

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
OTC NCT00610480 ↗ Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops Completed Investigator initiated study N/A 2007-11-01 The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
OTC NCT00610480 ↗ Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops Completed University of Texas Southwestern Medical Center N/A 2007-11-01 The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for FLUORESCEIN SODIUM

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00345241 ↗ Effects of Systane Versus Saline in Maintaining Tear Film Stability at Determined Time Points Completed University of Texas Southwestern Medical Center N/A 2006-01-01 To evaluate tear film stability of a market lubricant therapeutic eye drop versus saline when using Evaporometry and Interferometry in patients with a diagnosis of Keratoconjunctivitis Sicca (KCS). The purpose of this research is to evaluate evaporative parameters and tear film quality when using Systane lubricating eye drops versus saline in the eyes of dry eye patients at pre-instillation and at 30 and 60 minutes post instillation of drop(s).
NCT00355459 ↗ A Prospective Clinical Study Assessing the Effects of Tetracycline Antibiotic on Tear Film and Tear Lipid Composition Within a Population of Patients Diagnosed With Blepharitis and Dry Eye Disease Withdrawn University of Texas Southwestern Medical Center N/A 2005-08-01 The purpose of this research project is to determine the effects of oral tetracycline such as Minocycline (Minocin) on tear film composition and tear lipid (meibomian gland secretions) characteristics in patients with chronic Blepharitis and associated dry eyes.
NCT00531024 ↗ Systemic Avastin Therapy in Age-Related Macular Degeneration Completed The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery Phase 2/Phase 3 2005-08-01 Choroidal neovascularisation (CNV) in age-related macular degeneration is one of the major causes of blindness in the western world. It is already known that the vascular endothelial growth factor (VEGF) plays a major role in the development of CNV. Photodynamic therapy (PDT), subretinal surgery, and intravitreal injection of VEGF- inhibitors are the common treatments. These methods are either very invasive or need to be repeated several times over long periods of time in order show some effect. Furthermore PDT can only be performed in eyes with pigment epithelium detachments (PED) of maximum 50% of the avascular zone, while intravitreal injections can lead to endophthalmitis and acute glaucoma. A systemic treatment, which would only need to be administered 3 times within 6 weeks would be a major effort in macular degeneration therapy.
NCT00211445 ↗ Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC) Completed Manhattan Eye, Ear & Throat Hospital Phase 2 2002-07-01 Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. The etiology is unknown, but according to the studies this condition is more common in young males and is associated with type A personality. Clinically, CSC is characterized by serous retinal detachment and area of leakage of in the subretinal space. The standard of care for acute CSC is observation for a period of up to 3 months. If there is no complete resolution of the retinal detachment by 3 months, there is an indication for focal laser photocoagulation therapy of the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of detachment. However, laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of RPE thus rendering laser treatment ineffective.The purpose of this medical research study is to evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on observations in exudative type of AMD patients treated with Photodynamic Therapy using Verteporfin.
NCT00008515 ↗ Fluocinolone Implant to Treat Macular Degeneration Completed National Eye Institute (NEI) Phase 1 2001-01-01 This study will test the safety and effectiveness of a fluocinolone implant to treat age-related macular degeneration. This eye disease can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. It is the leading cause of vision loss in people over age 60. The fluocinolone implant is a tiny plastic rod with a pellet of the steroid fluocinolone on the end. The pellet slowly dissolves and releases the medication into the fluid in the eye. Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina. These abnormal vessels leak blood under the macula, the part of the retina that determines central vision. Tissue studies show evidence of inflammation in the retinas of patients. This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss. Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision. Patients 50 years of age and older with age-related macular degeneration may be eligible for this study. Study patients will be randomly assigned to one of two treatment groups. One will receive a 0.5-mg dose implant; the other will receive a 2-mg dose implant. Theoretically, the implants can release the medicine for 2 to 3 years. Participants will have a medical history, physical examination and complete eye examination. The latter will include a vision test, eye pressure measurement, examination of the pupils, lens, retina, and eye movements. Photographs of the eye will be taken with a special camera. Patients will also undergo fluorescein angiography, a test that takes pictures of the retina using a yellow dye called sodium fluorescein. The dye is injected into the blood stream through a vein. After it reaches the blood vessels of the eye, photographs are taken of the retina. When the above tests are completed, patients will be scheduled for surgery to place the implant. The procedure will be done under either local or general anesthesia. Follow-up visits will be scheduled 1, 2, 4, and 6 weeks after surgery, then at 3 and 6 months after surgery, and then every 6 months until the implant is depleted of medicine or is removed. Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects, if any.
NCT00001863 ↗ Leflunomide to Treat Uveitis Completed National Eye Institute (NEI) Phase 2 1999-03-01 This study will investigate the safety and effectiveness of the drug Leflunomide to treat uveitis-an inflammation of the eye caused by an immune system abnormality. Leflunomide suppresses immune system activity and has been shown to control autoimmune diseases, such as arthritis (joint inflammation), in animals. It has also improved symptoms in patients with rheumatoid arthritis, and the Food and Drug Administration has approved it for treating patients with this disease. Eye and joint inflammation may have similar causes, and medicines for arthritis often help patients with eye inflammation. This study will examine whether Leflunomide can help patients with uveitis. Patients with uveitis who are not responding well to steroid treatment and patients who have side effects from other medicines used to treat uveitis (such as cyclosporine, cyclophosphamide, methotrexate or azathioprine) or have refused treatment because of possible side effects of these medicines may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood test and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina) with an ophthalmoscope and the front of the eye with a microscope. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the bloodstream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina. Study participants will be divided into two groups. One group will take 100 milligrams of Leflunomide once a day for 3 days and then 20 milligrams once a day for 6 months. The other group will take a placebo-a pill that looks like the Leflunomide pill but does not contain the medicine. All patients in both groups will also take prednisone. Patients will have follow-up examinations at weeks 1, 4, 8, 12, 16, and 24 (6 months) of the study. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine. Those who do well and want to continue their assigned treatment after 6 months can continue that treatment for another 6 months and will have follow-up exams at months 9 and 12.
NCT00000115 ↗ Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema Completed National Eye Institute (NEI) Phase 2 1990-12-01 To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for FLUORESCEIN SODIUM

Condition Name

3332000.511.522.53Dry EyeDry Eye DiseaseMacular DegenerationStage IB Skin Melanoma[disabled in preview]
Condition Name for FLUORESCEIN SODIUM
Intervention Trials
Dry Eye 3
Dry Eye Disease 3
Macular Degeneration 3
Stage IB Skin Melanoma 2
[disabled in preview] 0
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Condition MeSH

1010640-101234567891011Keratoconjunctivitis SiccaDry Eye SyndromesEye DiseasesMacular Degeneration[disabled in preview]
Condition MeSH for FLUORESCEIN SODIUM
Intervention Trials
Keratoconjunctivitis Sicca 10
Dry Eye Syndromes 10
Eye Diseases 6
Macular Degeneration 4
[disabled in preview] 0
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Clinical Trial Locations for FLUORESCEIN SODIUM

Trials by Country

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Trials by Country for FLUORESCEIN SODIUM
Location Trials
United States 27
China 3
Canada 3
Korea, Republic of 1
Lebanon 1
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Trials by US State

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Trials by US State for FLUORESCEIN SODIUM
Location Trials
New York 6
Texas 4
Massachusetts 3
Florida 3
California 2
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Clinical Trial Progress for FLUORESCEIN SODIUM

Clinical Trial Phase

19.5%75.6%0051015202530Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for FLUORESCEIN SODIUM
Clinical Trial Phase Trials
Phase 4 8
Phase 3 1
Phase 2/Phase 3 1
[disabled in preview] 31
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Clinical Trial Status

52.3%20.5%11.4%15.9%04681012141618202224CompletedUnknown statusRecruiting[disabled in preview]
Clinical Trial Status for FLUORESCEIN SODIUM
Clinical Trial Phase Trials
Completed 23
Unknown status 9
Recruiting 5
[disabled in preview] 7
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Clinical Trial Sponsors for FLUORESCEIN SODIUM

Sponsor Name

trials0123456789National Cancer Institute (NCI)Roswell Park Cancer InstituteNational Eye Institute (NEI)[disabled in preview]
Sponsor Name for FLUORESCEIN SODIUM
Sponsor Trials
National Cancer Institute (NCI) 3
Roswell Park Cancer Institute 3
National Eye Institute (NEI) 3
[disabled in preview] 9
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Sponsor Type

76.8%11.6%11.6%0-50510152025303540455055OtherIndustryNIH[disabled in preview]
Sponsor Type for FLUORESCEIN SODIUM
Sponsor Trials
Other 53
Industry 8
NIH 8
[disabled in preview] 0
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Fluorescein Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Fluorescein sodium, a fluorescent dye, has been increasingly utilized in various medical fields, including neurosurgery and ophthalmology. This article delves into the recent clinical trials, market analysis, and future projections for fluorescein sodium.

Clinical Trials and Efficacy

Neurosurgical Applications

In the realm of neurosurgery, fluorescein sodium has shown promising results in the resection of brain gliomas. A study conducted at Beijing Tiantan Hospital involved 50 clinical cases of brain gliomas treated with the combined application of sodium fluorescein and neuronavigation techniques. The results indicated that the consistency between fluorescein and neuronavigation was higher in brainstem tumors than in supratentorial tumors. Moreover, a dose of 2.5 mg/kg of sodium fluorescein was found to be sufficient for pediatric patients, achieving similar visualization to the 5 mg/kg dose used in adults without adverse effects[1].

A multicentric prospective phase II trial (FLUOGLIO) further validated the efficacy of fluorescein-guided surgery for high-grade gliomas. The trial involved 46 patients and demonstrated a high rate of complete tumor removal (82.6%) with no adverse reactions related to the administration of fluorescein. The sensitivity and specificity of fluorescein in identifying tumor tissue were 80.8% and 79.1%, respectively[4].

Safety and Dosage

The safety profile of fluorescein sodium has been a critical aspect of these studies. Historically, high doses of sodium fluorescein were associated with allergic reactions, but the current dosages of 5 mg/kg for adults and 2.5 mg/kg for children have been found to be safe and effective. The absence of adverse reactions in these trials underscores the safety of fluorescein sodium when used appropriately[1][4].

Market Analysis

Current Market Size and Growth

The fluorescein sodium market has experienced significant growth in recent years. The global market for fluorescein sodium injections is projected to continue its upward trend from 2023 to 2031. This growth is driven by the increasing demand for diagnostic and surgical applications, particularly in hospitals and clinics[2].

Segmentation and Distribution

The market is segmented based on type (100 mg/1mL, 250 mg/1mL) and application (hospital, clinic), as well as geographical regions. The report highlights that the market dynamics are influenced by both intrinsic factors such as drivers and restraints, and external factors like market opportunities and challenges[2].

Ophthalmic Applications

In ophthalmology, fluorescein sodium ophthalmic strips are widely used for diagnostic purposes. The global market for these strips was estimated to be worth $256.3 million in 2023 and is forecasted to reach $349.2 million by 2030, with a CAGR of 4.3% during the forecast period. This growth is attributed to the increasing number of patients undergoing ophthalmic diagnoses and the convenience of using fluorescein dye in the form of strips[5].

Market Projections

Forecasted Growth

The fluorescein sodium market is poised for significant growth over the next several years. The forecast period from 2023 to 2031 indicates sustained expansion, driven by the increasing adoption of fluorescein-guided surgeries and diagnostic procedures. The market is expected to benefit from advancements in medical technology and the expanding need for precise diagnostic tools[2].

Regional Outlook

Geographically, the market is expected to grow across various regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region is anticipated to be a key driver of growth due to the increasing healthcare infrastructure and the rising demand for advanced diagnostic and surgical techniques[2].

Key Players and Competitive Landscape

The market for fluorescein sodium is characterized by a competitive landscape involving several key players. Companies such as Biotech, Hilco Vision, OptiGlo, and Bausch Health are prominent in the ophthalmic segment, while other companies are involved in the broader medical applications of fluorescein sodium. The competitive landscape is expected to remain dynamic, with companies focusing on innovation and market expansion[5].

Conclusion

Fluorescein sodium has emerged as a valuable tool in both neurosurgery and ophthalmology, with clinical trials demonstrating its efficacy and safety. The market for fluorescein sodium is projected to grow significantly, driven by increasing demand for precise diagnostic and surgical techniques. As the healthcare sector continues to evolve, fluorescein sodium is likely to play an increasingly important role.

Key Takeaways

  • Fluorescein sodium is effective and safe for use in neurosurgical procedures, particularly in the resection of brain gliomas.
  • The dye selectively accumulates in high-grade glioma tissue, enhancing tumor visualization during surgery.
  • The market for fluorescein sodium is growing rapidly, with forecasts indicating sustained expansion from 2023 to 2031.
  • Ophthalmic applications of fluorescein sodium, such as ophthalmic strips, are also experiencing significant growth.
  • Key players in the market are focusing on innovation and market expansion to capitalize on the growing demand.

FAQs

What is the primary use of fluorescein sodium in neurosurgery?

Fluorescein sodium is primarily used in neurosurgery to enhance the visualization of brain tumors, particularly high-grade gliomas, during surgical resection.

What are the typical dosages of fluorescein sodium used in clinical settings?

For adults, the typical dosage is 5 mg/kg, while for pediatric patients, a dose of 2.5 mg/kg is sufficient and safe.

What are the market projections for fluorescein sodium injections?

The market for fluorescein sodium injections is projected to continue its significant growth from 2023 to 2031, driven by increasing demand in hospitals and clinics.

How is fluorescein sodium used in ophthalmology?

In ophthalmology, fluorescein sodium is used in the form of ophthalmic strips for diagnostic purposes, such as performing angiography or angioscopy of the retina and iris.

What are the key regions driving the growth of the fluorescein sodium market?

The key regions driving the growth include North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa, with the Asia-Pacific region expected to be a significant driver.

Sources

  1. Combined Application of Sodium Fluorescein and Neuronavigation Techniques in the Resection of Brain Gliomas. Frontiers in Neurology, 2021.
  2. Global Fluorescein Sodium Injection Market Size, Trends and Forecasts. Market Research Intellect, December 2024.
  3. Altaire Pharmaceuticals, Inc. - Drug pipelines, Patents, Clinical trials. Synapse, Patsnap.
  4. Fluorescein-Guided Surgery for Resection of High-Grade Gliomas. Clinical Cancer Research, 2024.
  5. Fluorescein Sodium Ophthalmic Strip - Market Size. Valuates Reports, 2024.

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