Diabetic Retinopathy Clinical Trial
Official title:
A Randomized, Double-masked, Placebo-controlled Phase 1b/2a Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ in Patients With Non-proliferative Diabetic Retinopathy Without Center-involved Diabetic Macular Edema.
Diabetic retinopathy (DR) is a common complication of diabetes mellitus that leads to loss of vision and blindness among working age adults. An ideal adjunctive agent for treating DR hence should be polymorphic and possess antiangiogenic, neuroprotective, anti-inflammatory, anti-oxidant as well as anti-ischaemic properties.Natureceuticals Sdn Bhd assessed the efficacy of core ingredient of Nuvastatic™, Lanctos 75™ for the treatment and management of the diabetic retinopathic condition.
Diabetic retinopathy (DR) is a common complication of diabetes mellitus that leads to loss of
vision and blindness among working age adults. During progression of DR, patients can develop
diabetic macular edema (DME), which is characterized by the thickening of the macula caused
by the breakdown of the blood-retinal barrier and consequent retinal vascular
hyperpermeability. In 2010, the global prevalence of DR among adults with diabetes mellitus
aged 20-79 years was estimated to be 34.6% for any DR and 6.81% for DME. DME is the leading
cause of vision loss among patients with DR. It is associated with the type of diabetes, and
increases with the duration and severity of disease. Other significant risk factors common to
DR and DME include hyperglycemia and hypertension. DME negatively impacts patients'
health-related quality of life and represents an economic burden due to the increased use of
healthcare resources by affected patients.
In DR, which is a complex multifactorial disease, basically the retinal neovascularization
occurs with the disturbance of physiological angiogenesis due to creation of hypoxic
condition, which induces the oxygen demand in the retina (Roth, 1977; Smith et al., 1994;
Chen and Smith, 2007). Consequently, in response to induced hypoxia, excessive production and
over expression of VEGF and other pro-angiogenic factors take place in the retina. This
ultimately induces the situation so called "pathological neovascularization" (Aiello et al.,
1994; Folkman, 2006). Retinal ischemia is a common precursor to vitreal neovascularization in
retinal diseases (Tolentino and Adamis, 1998) and is strongly associated with a local
inflammatory response in the ischemic retina (Barouch et al., 2000).
While there is no curative treatment available for DME, laser photocoagulation represents an
effective treatment to preserve vision. However, this treatment modality is limited by its
inability to restore vision once it has been lost. The current standard of care for DME
includes intravitreal anti-vascular endothelial growth factor (VEGF) therapeutics and
corticosteroids. Clinical studies have confirmed that monthly intravitreal treatment with the
anti-VEGF treatment can improve vision, with up to 45% of patients gaining ≥ 15 letters in
best-corrected visual acuity (BCVA) after 24 months. Similar improvements were found after
treatment with the anti-VEGF antibodies. Despite the proven efficacy of VEGF inhibitors, the
requirement of frequent injections causes a high rate of treatment discontinuation among
patients with DME and represents a major limitation.
Thus, current pharmacological treatments target single pathogenic processes with a narrow
therapeutic range and may cause adverse side effects leading to undesired systemic effects.
The presence of potential side effects and the significant proportion of patients who do not
respond to treatment suggest that there remains a need for the development of improved
therapies for DR and DME.
An ideal adjunctive agent for treating DR hence should be polymorphic and possess
antiangiogenic, neuroprotective, anti-inflammatory, anti-oxidant as well as anti-ischaemic
properties.
We have assessed the efficacy of core ingredient of Nuvastatic™, Lanctos 75™ for the
treatment and management of the diabetic retinopathic condition. These scientific studies
have shown that the standardized extract of O. stamineus (Lanctos 75™) in mediates
antiangiogenic actions via blocking VEGF pathway. We demonstrated the potent antiangiogenic
activity of the standardized extract of O. stamineus and prevention activity of the extract
against human breast tumor in xenograft model. In addition, it is reported that, the extract
was found to specifically inhibit VEGF expression and VEGFR phosphorylation known to be
up-regulated in new blood vessel formation which in turn leads to suppression of
vascularization and thereby ultimately the growth of tumor will be affected. Rosmarinic acid
present in the extract could be involved in cell cycle arrest in the G0/G1 and G1/S phases,
exhibiting an anti-proliferative effect of thus suggesting that the proliferative vascular
diseases including retinopathy might be the potential target for the pharmacological
application of rosmarinic acid. Also, the key active ingredients in the extract are
rosmarinic acid mainly, and sinensetin, eupatorin and betulinic acid, which are readily
absorbed into the plasma and exert that conferred the synergistic pharmacological response
such as anti-inflammatory, antioxidant, analgesic and neuroprotective effects.
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