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

ConditionsDiabetic Macular EdemaDME
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSciNeuro

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • SNP318

    Drug

    Once daily, oral administration

  • Placebo

    Drug

    Once daily, oral administration

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SNP318Experimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety Events

Incidence of adverse events (AEs) / serious adverse events (SAEs)

Time frame
12 weeks
2

Central Subfield Thickness (CST)

Spectral Domain Optical Coherence Tomography (SD-OCT) measurements of CST

Time frame
12 weeks

Secondary outcomes

1

Visual Acuity

Best Corrected Visual Acuity (BCVA) assessed according to ETDRS criteria

Time frame
12 weeks
2

Pharmacokinetics (PK)

Plasma concentrations of SNP318

Time frame
12 weeks
3

Pharmacodynamics

Plasma Lp-PLA2 activity

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SciNeuro

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: