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Recruiting NCT07368959

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

Phase III Interventional Corneal Edema Corneal Endothelial Dysfunction Fuchs Endothelial Corneal Dysfunction Pseudophakic Bullous Keratopathy (PBK)

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: Combination Product: AURN001 + Y-27632, Placebo.
Who it may be relevant to
Registry conditions: Corneal Edema, Corneal Endothelial Dysfunction, Fuchs Endothelial Corneal Dysfunction, Pseudophakic Bullous Keratopathy (PBK). 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
United States
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

ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)

Overview

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.

Interventions

  • Drug Combination Product: AURN001 + Y-27632
    AURN001 will be injected to the anterior chamber of the eye.
  • Other Placebo
    Placebo control will be injected to the anterior chamber of the eye.

Primary outcome measures

  • Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6 [Time frame: At Month 6]
Secondary outcome measures (2)
  • Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6 [Time frame: Baseline (Day 1) and At Month 6]
  • Change from baseline in BCVA at Month 6 [Time frame: Baseline (Day 1) and At Month 6]

Eligibility criteria

Key Ocular Inclusion Criteria:

(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 Exclusion Criteria:

(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.

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

United States · 12 centers
  • Investigational Site 2 — Mesa
  • Investigational Site 6 — Little Rock
  • Investigational Site 9 — Fort Collins
  • Investigational Site 7 — Atlanta
  • Investigational Site 4 — Kansas City
  • Investigational Site 11 — Leland
  • Investigational Site 5 — Winston-Salem
  • Investigational Site 3 — Cynwyd
  • … and 4 more centers

Identifiers

NCT: NCT07368959 · ABA-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗