Recruiting PHASE3 Corneal Edema

Tests treatment safety and results for Corneal Edema

Official title AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction

ClinicalTrials.gov ID: NCT07368959

What this study is testing

What is Combination Product: AURN001 + Y-27632?

Combination Product: AURN001 + Y-27632 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for corneal edema.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Key Ocular (All ocular criteria apply to the study eye unless noted otherwise)
  • Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
  • BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)
  • Be pseudophakic with PCIOL Key Ocular

You likely can't join if

  • (All ocular criteria apply to the study eye unless noted otherwise)
  • Have progressive corneal dystrophies or degenerations
  • Have visually significant corneal or other ocular pathologies Other inclusion/exclusion criteria may apply.

The study team makes the final eligibility decision.

Where it's taking place

  • Mesa, Arizona, United States
  • Little Rock, Arkansas, United States
  • Fort Collins, Colorado, United States
  • Atlanta, Georgia, United States
  • Kansas City, Missouri, United States
  • Leland, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cynwyd, Pennsylvania, United States
  • Plymouth Meeting, Pennsylvania, United States
  • Ladson, South Carolina, United States
  • San Antonio, Texas, United States
  • Spring, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Mesa, Arizona, United States; Little Rock, Arkansas, United States; Fort Collins, Colorado, United States; Atlanta, Georgia, United States; Kansas City, Missouri, United States; Leland, North Carolina, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.