NCT07199777

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started Nov 2025

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Nov 2025Mar 2027

First Submitted

Initial submission to the registry

September 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 22, 2025

Last Update Submit

September 22, 2025

Conditions

Diabetic Macular EdemaDME

Outcome Measures

Primary Outcomes (2)

  • Safety Events

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

    12 weeks

  • Central Subfield Thickness (CST)

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

    12 weeks

Secondary Outcomes (3)

  • Visual Acuity

    12 weeks

  • Pharmacokinetics (PK)

    12 weeks

  • Pharmacodynamics

    12 weeks

Study Arms (2)

SNP318

EXPERIMENTAL
Drug: SNP318

Matching Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SNP318DRUG

Once daily, oral administration

SNP318
PlaceboDRUG

Once daily, oral administration

Matching Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

September 30, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

September 30, 2025

Record last verified: 2025-09