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

ConditionsCorneal EdemaCorneal Endothelial DysfunctionFuchs Endothelial Corneal DysfunctionPseudophakic Bullous Keratopathy (PBK)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAurion Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Have progressive corneal dystrophies or degenerations

Have visually significant corneal or other ocular pathologies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combination Product: AURN001 + Y-27632

    Drug

    AURN001 will be injected to the anterior chamber of the eye.

  • Placebo

    Other intervention

    Placebo control will be injected to the anterior chamber of the eye.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: AURN001Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6

Time frame
Baseline (Day 1) and At Month 6
2

Change from baseline in BCVA at Month 6

Time frame
Baseline (Day 1) and At Month 6

Other outcomes

Sponsors and contacts

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

Aurion Biotech

Lead sponsor

Source ClinicalTrials.gov
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