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A Randomized, Double-Blind, Placebo-Controlled Trial of Curcumin in Leber's Hereditary Optic Neuropathy (LHON)

2014-07-24 14:20:25 | BioPortfolio

Summary

Background Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited ocular disorder associated with a mutation in mtDNA . The common manifestation is visual loss which caused by the respiratory chain enzymes complex dysfunction resulting in increased oxidative stress enzymes production.

Purpose To determine whether curcumin which is an antioxidant agent is beneficial to the patients with 11778 LHON mutation.

Material and Method Seventy patients with 11778 LHON mutation were randomly treated with oral curcumin (500 mg/day) and placebo for 1 year. The visual acuity, computerized visual field, electrophysiologic parameters and oxidative stress enzymes in plasma were compared before and after treatment at 3, 6, and 12 months interval.

Description

Leber's hereditary optic neuropathy (LHON) is a maternally inherited disease that is characterized by a simultaneous or more common sequential bilateral loss of central vision, which typically occurs during the teenager years or early adulthood. The disease may be progressive and the patients eventually become blind. In contrast to blindness in patients caused by congenital diseases, the patients who develop blindness caused by LHON will have more trouble in their life because they previously had better vision. Although LHON is associated with mitochondrial DNA mutation at a variable nucleotide position but no certain mechanism of optic nerve injury has been found. It has been postulated that a defect in a complex of respiratory chain enzyme which is caused by mitochondrial DNA dysfunction, results in an increase of free radical substances that interfere with optic nerve function in LHON. Some antioxidant substances have been used to decrease the progression of visual impairment. However, there have been few therapeutic trials for LHON.

Curcumin, a component of tumeric, which comes from the root Curcumin longa has antioxidant, anti-inflammatory and anti-carcinogenic activities. There is some evidence which suggests that curcumin contributes to the in vitro removal of free radical gradients in thalassemic serum and to a clinical improvement of thalassemic patients. We propose a randomized controlled trial study of curcumin, which is an antioxidant substance, for LHON. This study will provide not only an insight into the therapeutic efficacy of curcumin, a kind of Thai herb, for LHON but also the development of future therapeutic strategies to prevent blindness.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Optic Atrophy, Hereditary, Leber

Intervention

curcumin

Location

Professor Wanicha Chuenkongkaew
Bangkok
Thailand
10700

Status

Recruiting

Source

Mahidol University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:20:25-0400

Clinical Trials [606 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy Study of Gene Therapy for The Treatment of Leber's Hereditary Optic Neuropathy

This study is meant to evaluate the safety and efficacy of rAAV2-ND4 treatment for Leber hereditary optic neuropathy with the G11778A mutation in mitochondrial DNA.

RESCUE and REVERSE Long-term Follow-up

The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4 mitocho...

Safety and Efficacy Study of rAAV2-ND4 Treatment of Leber Hereditary Optic Neuropathy (LHON)

This study is meant to assess the safety and efficacy of rAAV2-ND4 treatment of Leber hereditary optic neuropathy with 11778 LHON mutation.

Efficacy and Safety Study of Bilateral Intravitreal Injection of GS010 for the Treatment of Vision Loss up to 1 Year From Onset in LHON Due to the ND4 Mutation

The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene therapy, in improving the retina functional & structural outcomes in subjects with LHON due to the G11...

Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with ...

PubMed Articles [1557 Associated PubMed Articles listed on BioPortfolio]

Hereditary Optic Neuropathies.

Hereditary optic nerve disorders are rare. For ophthalmologists, Leber's hereditary optic neuropathy (LHON) and autosomal dominant optic atrophy (ADOA) are of particular relevance. LHON and ADOA are d...

Leber hereditary optic neuropathy.

Leber hereditary optic neuropathy is characterized by bilateral, painless loss of vision in children and young adults (generally up to 25 years old). Since its first description in 1871, the understan...

Topographic Macular Microvascular Changes and Correlation with Visual Loss in Chronic Leber's Hereditary Optic Neuropathy.

To study the macular microvascular networks in patients affected by chronic Leber's hereditary optic neuropathy (LHON) using optical coherence tomography angiography (OCTA), and to quantify these chan...

Visual Field Variability after Gene Therapy for Leber's Hereditary Optic Neuropathy.

To assess changes in visual field (VF) values after gene therapy for Leber's hereditary optic neuropathy (LHON).

Generation of patient-specific induced pluripotent stem cells from Leber's hereditary optic neuropathy.

Leber's hereditary optic neuropathy (LHON) is a maternally inherited mitochondrial disease caused by homoplasmic point mutations in complex I subunit genes of mitochondrial DNA. In this report, we gen...

Medical and Biotech [MESH] Definitions

Hereditary conditions that feature progressive visual loss in association with optic atrophy. Relatively common forms include autosomal dominant optic atrophy (OPTIC ATROPHY, AUTOSOMAL DOMINANT) and Leber hereditary optic atrophy (OPTIC ATROPHY, HEREDITARY, LEBER).

Atrophy of the optic disk which may be congenital or acquired. This condition indicates a deficiency in the number of nerve fibers which arise in the RETINA and converge to form the OPTIC DISK; OPTIC NERVE; OPTIC CHIASM; and optic tracts. GLAUCOMA; ISCHEMIA; inflammation, a chronic elevation of intracranial pressure, toxins, optic nerve compression, and inherited conditions (see OPTIC ATROPHIES, HEREDITARY) are relatively common causes of this condition.

Dominant optic atrophy is a hereditary optic neuropathy causing decreased visual acuity, color vision deficits, a centrocecal scotoma, and optic nerve pallor (Hum. Genet. 1998; 102: 79-86). Mutations leading to this condition have been mapped to the OPA1 gene at chromosome 3q28-q29. OPA1 codes for a dynamin-related GTPase that localizes to mitochondria.

A rare degenerative inherited eye disease that appears at birth or in the first few months of life that results in a loss of vision. Not to be confused with LEBER HEREDITARY OPTIC NEUROPATHY, the disease is thought to be caused by abnormal development of PHOTORECEPTOR CELLS in the RETINA, or by the extremely premature degeneration of retinal cells.

A maternally linked genetic disorder that presents in mid-life as acute or subacute central vision loss leading to central scotoma and blindness. The disease has been associated with missense mutations in the mtDNA, in genes for Complex I, III, and IV polypeptides, that can act autonomously or in association with each other to cause the disease. (from Online Mendelian Inheritance in Man, http://www.ncbi.nlm.nih.gov/Omim/, MIM#535000 (April 17, 2001))

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