RecruitingPhase 2

A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01

United States100 participantsStarted 2025-02-11

Plain-language summary

The goal of this clinical trial is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of VX-01 as stand-alone treatment for Diabetic Retinopathy of Non-Proliferative Type (NPDR). The primary objective of the study is to evaluate the efficacy of daily oral doses of VX-01 versus placebo following 52 weeks of treatment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Of non-childbearing potential: post-menopausal or documented surgically sterile post hysterectomy (at least 1 month prior to Screening)
✓. Or, if of childbearing potential, must have a negative serum pregnancy test at Screening and must use 2 acceptable forms of contraception, starting at Screening and throughout the study period and for 28 days after the final IP administration.

Exclusion criteria

✕. Focal or grid laser photocoagulation within the past 6 months prior to Screening or pan-retinal photocoagulation (PRP) at any time.
✕. Systemic or intravitreal anti-vascular endothelial growth factor (VEGF) agents within the last 12 months prior to Screening.
✕. Intraocular, sub-tenon or periocular steroids, including triamcinolone and dexamethasone implant within the last 6 months, or suprachoroidal triamcinolone within the last 3 months prior to Screening.
✕. Fluocinolone implant within the last 3 years prior to Screening.
✕. Prior treatment for NPDR with any other treatment which is not labelled for NPDR within 1 year prior to Screening (e.g., calcium dobesilate, fibrate medication).
✕. Vitrectomy at any timepoint prior to Screening.
✕. Yttrium-Aluminium-Granate (YAG) capsulotomy within 3 months prior to Screening.

What they're measuring

Evaluate the efficacy of oral doses of VX-01 in subjects compared to placebo following 1 year of treatment.

Timeframe: From enrollment to the end of treatment at week 52

Trial details

NCT IDNCT06770933

SponsorVantage Biosciences Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Steffy George

+44 7450953382 steffy.george@vantage-biosciences.com

View on ClinicalTrials.gov More Diabetic Retinopathy trials