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NCT02753400 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy

A Phase 2 study of Proliferative Diabetic Retinopathy, sponsored by Kubota Vision.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target
1
Study location

NCT02753400: Completed Phase 2 study of Proliferative Diabetic Retinopathy, sponsored by Kubota Vision.

NCT02753400 is a Phase 2 study of Proliferative Diabetic Retinopathy that has completed, run by Kubota Vision. The registered enrollment target is 24 participants, below the 212-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02753400, a Phase 2 study of Proliferative Diabetic Retinopathy, has completed, sponsored by Kubota Vision.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.

Primary Outcome

All values for IL-1β were below the lower limit of detection and were recorded as zero. Tests for IP-10 and MCP-1 failed accuracy and stability testing during assay development and were dropped from the study. The assay for PDGF-AA could not be developed.and results were not reported.

Interventions

  • OTHER Placebo
  • DRUG emixustat hydrochloride

Study Locations (1)

California

  • Retina Institute of California - Arcadia

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-05
Est. Completion 2017-12
Phase Phase 2
Kubota Vision

16 total trials

What the finished NCT02753400 record still lists

NCT02753400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 212-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02753400 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT02753400 about?

NCT02753400 is a clinical study titled "Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy". To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.

What is the current status of trial NCT02753400?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2016-05. Estimated completion is 2017-12.

What conditions does trial NCT02753400 study?

This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy.

What interventions are being tested in trial NCT02753400?

The interventions under investigation include: Placebo (OTHER), emixustat hydrochloride (DRUG).

Who is sponsoring clinical trial NCT02753400?

This trial is sponsored by Kubota Vision, which has 16 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02753400 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02753400, the US trial registry maintained by the National Library of Medicine. NCT02753400 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.