A study to evaluate efficacy and safety of Orally Administered Extract of Orthosiphon stamineus (Nuvastaticâ„¢ - C5OSEW5050ESA) for 12 months in Patients With Non-proliferative Diabetic Retinopathy Without Center-involved Diabetic Macular Edema.
- Conditions
- Retinal disorders in diseases classified elsewhere,
- Registration Number
- CTRI/2019/10/021540
- Lead Sponsor
- Natureceuticals Sdn Bhd
- Brief Summary
Diabetic retinopathy(DR) is a common complication of diabetes mellitus that leads to loss of visionand blindness among working age adults. During progression of DR, patientscan develop diabetic macular edema (DME), which is characterized by thethickening of the macula caused by the breakdown of the blood-retinal barrier andconsequent retinal vascular hyperpermeability. While there is nocurative treatment available for DME, laser photocoagulation represents aneffective treatment to preserve vision. However, this treatment modality is limitedby its inability to restore vision once it has been lost. The currentstandard of care for DME includes intravitreal anti-vascular endothelial growthfactor (VEGF) therapeutics and corticosteroids. Thus, currentpharmacological treatments target single pathogenic processes with a narrowtherapeutic range and may cause adverse side effects leading to undesiredsystemic effects. The presence of potential side effects and the significantproportion of patients who do not respond to treatment suggest that thereremains a need for the development of improved therapies for DR and DME. As the bioactive principles of study product showed promisingresults, the current clinical study has been conceptualized and designed toassess the safety and efficacy of orally administered IP (1000mg thrice daily ) for 12 monthstreatment period in the Type -2 diabetic patients with non-proliferativediabetic retinopathy without center-involved diabetic macular edema. The study population will be restricted tonon-insulin dependent diabetic patients as maximum as possible to avoid anyinterference of the intensive insulin treatment .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
- Type-2 Diabetes mellius (NIDDM) patients of both genders aged 18–65 years.
- Able and willing to provide written informed consent.
- Documented diagnosis of Type 2 diabetes mellitus a glycosylated hemoglobin A1c (HbA1c) of less than or equal to 12 at screening.
- Patients preferably on oral medications for DM.
- Meets specific ocular criteria for the study eye including but not limited to, the presence of non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) in the study eye at screening with NPDR level 47 or level 53, as determined by the central reading center (CRC) by using the DR severity scale (DRSS), for which treatment can be deferred for at least 4 weeks after Day 1 visit.
- Media clarity, pupillary dilation, and subject cooperation sufficient to obtain adequate assessments.
- (Subject has early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score less than or equal to 73 (Snellen 20/40) and greater than or equal to 24 (Snellen 20/320) at screening visit).
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Study Eye Inclusion Criteria Best corrected E-ETDRS visual acuity letter score ≥74 (i.e.20/32 or better) within 8 days of randomization.
- On clinical exam, definite retinal thickening due to DME within 3000 μm of the center of the macula but not involving the central subfield.
- Thickened non-central macular subfields on spectral domain OCT macular map that meet either of the following criteria: a.At least two non-central macular subfields with OCT thickness above threshold (average normal + 2 SD) from DRCR.net approved spectral domain OCT machines- see below.
- b.At least one non-central macular subfield with OCT thickness at least 15 μm above threshold (average normal + 2 SD) from DRCR.net approved spectral domain OCT machines—see DRCR.net procedures manual for threshold details.
- Central subfield thickness less than 250 microns obtained by one of the DRCR.net approved spectral domain OCT machines.
- •Insulin dependent Diabetes mellitus (IDDM or T1DM) patients.
- •Any condition that would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease or glycemic control).
- •History of myocardial infarction or other acute cardiac event.
- •History of chronic renal failure requiring dialysis or kidney transplant.
- •Prior participation in any clinical study.
- •Treatment with any investigational study drug within 30 days of screening.
- •Known allergy to study product.
- •Treatment with specific prohibited medications or therapy beginning 4 weeks prior to screening and throughout the duration of the study.
- •Subject with macular edema considered to be due to a cause other than DME, decrease in BCVA due to causes other than DME, significant macular ischemia, any other ocular disease that may cause substantial reduction in BCVA, active peri-ocular or ocular infection.
- •Subject with an history of following within 3 months prior to Day 1: non-infectious uveitis, high myopia (-8 diopter or more correction), pars plana vitrectomy, any ocular surgery, prior IVT, subtenon, or periocular, non-sustained release, steroid therapy, uncontrolled glaucoma, •History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- •Male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 30 days following completion of the study •Female subjects of childbearing potential who are not willing to practice a medically accepted method of birth control with their non-surgically sterile male sexual partner from screening through 30 days following completion of the study •Female subjects who are pregnant or lactating.
- •Subject has media clarity, papillary constriction (i.e., senile miosis), or subject lacks cooperation that would interfere with any study procedures, evaluations or interpretation of data.
- •Cataract surgery performed within 6 months prior to screening or planned during the trial; or any additional eye disease in the study eye that, in the opinion of the investigator, could compromise or alter visual acuity during the course of the study (e.g. vein occlusion, uncontrolled intraocular pressure (IOP) >24 mmHg on optimal medical treatment, glaucoma with visual field loss, uveitis or other ocular inflammatory disease, vitreomacular traction, monocular vision, history of ischemic optic neuropathy, or genetic disorders such as retinitis pigmentosa) •Active center-involved DME (CI-DME) on clinical examination and Optical Coherence Tomography (OCT) central subfield thickness in the study eye above 300 μm as measured by Optovue OCT or above 320 μm as measured by Heidelberg OCT •Anterior segment and vitreous abnormalities in the study eye that would compromise the adequate assessment of the best corrected visual acuity or an adequate examination of the posterior pole.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Central Subfield Retinal Thickness- Optical Coherence Tomography (OCT). baseline (day1), 6th Month and 12th Month. To compare the differences in protein biomarkers (VEGF and β-amyloid). baseline (day1), 6th Month and 12th Month.
- Secondary Outcome Measures
Name Time Method The proportion of patients with any ocular adverse events (according to Common Terminology Criteria for Adverse Events (CTCAE) over the on treatment period (from baseline up to 12 months) Change in Visual Acuity Letter Score from baseline over all Study Visits.
Trial Locations
- Locations (1)
SANJEEVANI NETHRALAYA & MEDICAL RESEARCH CENTER
🇮🇳Bangalore, KARNATAKA, India
SANJEEVANI NETHRALAYA & MEDICAL RESEARCH CENTER🇮🇳Bangalore, KARNATAKA, IndiaDR RAJESH PAREKHPrincipal investigator9945544744vision6by6@gmail.com