CompletedPhase 1/2

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

India100 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.
✓. Zeiss Cirrus
✓. Heidelberg Spectralis
✓. Optovue RTVue

What they're measuring

To evaluate efficacy of Nuvastatic - Retinal Thickness

Timeframe: 12 months

To evaluate efficacy of Nuvastatic - protein biomarkers

Timeframe: 12 months

To evaluate safety of Nuvastatic - Letter Score

Timeframe: 12 months

Trial details

NCT IDNCT04552600

SponsorNatureceuticals Sdn Bhd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-10

View on ClinicalTrials.gov More Diabetic Retinopathy trials