A Phase II, Double-Masked, Randomised, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy OF Non-Proliferative Type (NPDR)
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.
• Written informed consent must be obtained from the subject prior to any study-related procedures.
• Subject must be aged \> 18 years at the time of Screening.
• Subject must have a body mass index (BMI) of between 18 and 40 kg/m2, inclusive.
• Subject has a documented diagnosis of T1DM or T2DM.
• Subject has moderate to severe NPDR, as determined by a Central Reading Centre (CRC) using DRSS in at least one eye
• Subject must have clear ocular media and be able to undergo adequate pupil dilation to allow adequate fundus imaging of both eyes.
• Female subject must be either:
‣ 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.
• Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final IP administration.
• Male subject must be surgically sterile (\> 30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a female of childbearing potential, the couple should agree to use 2 acceptable contraceptive methods from Screening, during the study, and for 28 days after last IP administration.
∙ Female subject must not donate ova or male subject must not donate sperm starting at Screening and throughout the study period, and for 28 days after the final IP administration.
• Subject must have Best Corrected Visual Acuity (BCVA) assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) protocol letters score of ≥ 70 letters in study eye, and ≥ 20 letters in the non-qualified fellow eye.
• Subject must have the ability, in the opinion of the Investigator, and willingness to return for all scheduled visits and perform all assessments.
• Subject agrees not to participate in another interventional study after signing the informed consent and until the End of Study (EOS) visit has been completed.