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

NCT ID: NCT07199777

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Macular Edema DME

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SNP318

Group Type EXPERIMENTAL

SNP318

Intervention Type DRUG

Once daily, oral administration

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily, oral administration

Interventions

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SNP318

Once daily, oral administration

Intervention Type DRUG

Placebo

Once daily, oral administration

Intervention Type DRUG

Eligibility Criteria

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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)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SciNeuro

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SNP318-102

Identifier Type: -

Identifier Source: org_study_id