A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNP318, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema, DME. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug SNP318
Once daily, oral administration - Drug Placebo
Once daily, oral administration
Primary outcome measures
- Safety Events [Time frame: 12 weeks]
- Central Subfield Thickness (CST) [Time frame: 12 weeks]
Secondary outcome measures (3)
- Visual Acuity [Time frame: 12 weeks]
- Pharmacokinetics (PK) [Time frame: 12 weeks]
- Pharmacodynamics [Time frame: 12 weeks]
Eligibility criteria
Main Inclusion Criteria:
- Confirmed diabetes mellitus Type 1 or Type 2, with stable glycemic control
- Center-involved DME with CST >=320 µm (Study eye)
- BCVA between 82 and 25 letters, inclusive (Study eye)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07199777 · SNP318-102