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

SciNeuro

Status and phase: Not yet enrolling; Phase 2

Conditions: Diabetic Macular Edema; DME

Treatments: Drug: SNP318; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07199777

SNP318-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

SNP318

Experimental group

Treatment:

Drug: SNP318

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Placebo