Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy.

NCT04552600 | Completed Phase 1 DMC

• 1 other identifier: BIAG-CSP- 032
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

• To evaluate efficacy of Nuvastatic - Retinal Thickness

  Central Subfield Retinal Thickness

  12 months

• To evaluate efficacy of Nuvastatic - protein biomarkers

  protein biomarkers

  12 months

• To evaluate safety of Nuvastatic - Letter Score

  Visual Acuity Letter Score

  12 months

Secondary Outcomes (3)

• To evaluate short-term visual outcomes on severity

  12 months

• To evaluate short-term visual outcomes on zone diagnosis

  12 months

• To evaluate short-term visual outcomes on DRSS

  12 months

Study Arms (2)

NuvastaticTM 1000 mg

EXPERIMENTAL

NuvastaticTM 1000 mg(standardized extract of Orthosiphon Stamineus) will be given orally, three times per day for 12 months.

Drug: Nuvastatic

Placebo

ACTIVE COMPARATOR

NuvastaticTM (without active) will be given orally, three times per day for 12 months

Other: Placebo

Interventions

Nuvastatic DRUG

Phase 1b Interventional, multi-centered, double-masked, randomized

Also known as: Lanctos 75 standardized Orthosiphon Stamineus Extract

NuvastaticTM 1000 mg

Placebo OTHER

Phase 1b Interventional, multi-centered, double-masked, randomized

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 12.0% 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 ≤ 73 (Snellen 20/40) and ≥ 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.
• 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:
• 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.
• 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 \<250 microns obtained by one of the following DRCR.net approved spectral domain OCT machines:
• Zeiss Cirrus
• Heidelberg Spectralis

You may not qualify if:

• 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.
• Any laboratory abnormalities at screening.
• 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.

Sponsors & Collaborators

• Natureceuticals Sdn Bhd: lead
• Ministry of Agriculture, Malaysia: collaborator
• Quest International University, Malaysia.: collaborator
• Advanced Medical and Dental Institute (AMDI), Universiti Sains Malaysia: collaborator
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Fifepoint Multispeciality Hospital Pvt. Ltd.

Pune, Maharashtra, 411057, India

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Aman Shah Abdul Majid, Ph.D.

  Quest International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-masked, Placebo-controlled phase 1b/2a study

Study Record Dates

• First Submitted: September 5, 2020
• First Posted: September 17, 2020
• Study Start: September 1, 2019
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: December 12, 2025

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Completed study
• Access Criteria: Institutional Researcher

Locations

IN (1)