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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07199777

Enrollment

Registered

2025-09-30

Start date

2025-11-30

Completion date

2027-03-31

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, DME

Brief summary

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

Detailed description

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.

Interventions

DRUGSNP318

Once daily, oral administration

DRUGPlacebo

Once daily, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Safety Events	12 weeks	Incidence of adverse events (AEs) / serious adverse events (SAEs)
Central Subfield Thickness (CST)	12 weeks	Spectral Domain Optical Coherence Tomography (SD-OCT) measurements of CST

Secondary

Measure	Time frame	Description
Visual Acuity	12 weeks	Best Corrected Visual Acuity (BCVA) assessed according to ETDRS criteria
Pharmacokinetics (PK)	12 weeks	Plasma concentrations of SNP318
Pharmacodynamics	12 weeks	Plasma Lp-PLA2 activity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026