A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients

A Phase 2a, Randomized, Double-masked, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in Patients With Diabetic Macular Edema

The objective of this study is to assess the safety, efficacy, and tolerability of SNP318 in patients with DME.

DME is a prevalent complication of diabetic retinopathy, resulting in fluid accumulation in the macula due to the leakage of fluid from damaged retinal blood vessels. It is a leading cause of vision impairment in diabetic patients and can significantly affect quality of life if left untreated. SNP318 is a small molecule and selective inhibitor of Lp-PLA2. It plays a critical role in the regulation of the pro-neuroinflammatory pathway, which is implicated in the pathogenesis of multiple diseases.

This is a phase 2a, randomized, double-masked, placebo-controlled, multicenter study to evaluate the safety, tolerability, and efficacy of SNP318 in patients with Diabetic Macular Edema. Participants who consent will undergo a 3-week screening period to evaluate their eligibility. Once enrolled, participants will be randomized to receive orally either SNP318 or placebo for up to 12 weeks, and then enter into a 4-week follow up period.

Main Inclusion Criteria:

1. Confirmed diabetes mellitus Type 1 or Type 2, with stable glycemic control
2. Center-involved DME with CST >=320 µm (Study eye)
3. BCVA between 82 and 25 letters, inclusive (Study eye)
4. BCVA score ≥ 25 letters (Non-study eye)

Main Exclusion Criteria:

1. Use of the last intravitreal anti-VEGF injection in the study eye within 90 days prior to Screening