Clinical trial NCT06041256: A Phase 1/2 Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Official title: CLARA: A Phase 1/2 Multi-center, Randomized, Double-Masked, Prospective, Parallel-Arm Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Corneal Edema
Corneal Endothelial Dysfunction
Lead sponsor: Aurion Biotech
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare different doses of AURN001 in patients with corneal edema secondary to corneal endothelial dysfunction. The main questions the clinical trial aims to answer are whether AURN001 effective and safe. Participants will receive a single injection of AURN001. A comparison between low, medium, and high doses of AURN001 against the contribution of each element, cells alone and Y27632 alone, will be conducted to determine the effects on corneal edema.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)
* BCVA between 65 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (i.e., 0.4 LogMAR or approximate 20/50 Snellen equivalent) and 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent)

Exclusion Criteria:

* Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye
* Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments

Primary outcomes:
measure: BCVA - 15-letter improvement (3-line gain)
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Aurion Biotech site
state: Arkansas
city: Los Angeles
country: United States
facility: Aurion Biotech site
state: California
city: San Francisco
country: United States
facility: Aurion Biotech site
state: California
city: Atlanta
country: United States
facility: Aurion Biotech site
state: Georgia
city: Indianapolis
country: United States
facility: Aurion Biotech site
state: Indiana
city: Wichita
country: United States
facility: Aurion Biotech site
state: Kansas
city: Minnetonka
country: United States
facility: Aurion Biotech site
state: Minnesota
city: Garden City
country: United States
facility: Aurion Biotech site
state: New York
city: Winston-Salem
country: United States
facility: Aurion Biotech site
state: North Carolina
city: Cincinnati
country: United States
facility: Aurion Biotech site
state: Ohio
city: Oklahoma City
country: United States
facility: Aurion Biotech site
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Aurion Biotech site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Aurion Biotech site
state: South Dakota
city: Houston
country: United States
facility: Aurion Biotech site
state: Texas
city: Houston
country: United States
facility: Aurion Biotech site
state: Texas
city: Norfolk
country: United States
facility: Aurion Biotech site
state: Virginia
city: Seattle
country: United States
facility: Aurion Biotech site
state: Washington
city: Vancouver
country: Canada
facility: Aurion Biotech site
state: British Columbia
city: Oakville
country: Canada
facility: Aurion Biotech site
state: Ontario
city: Toronto
country: Canada
facility: Aurion Biotech site
state: Ontario
Study officials:
affiliation: Aurion Biotech
name: Study Manager, OD
role: STUDY_DIRECTOR
References: