Central retinal artery occlusion (CRAO) is an ophthalmologic emergency which leads to severe and permanent vision loss. There is no evidence-based therapy for CRAO. The objective of this GION study is to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in participants with acute non-arteritic CRAO.
This is a Phase II, double-masked, sham-controlled, multi-center, parallel-group study to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in patients with non-arteritic Central Retinal Artery Occlusion (CRAO) diagnosed and treated within 3-48 hours of disease onset. Participants will be randomized to high dose KUS121, low dose KUS121, or sham in a 1:1:1 ratio. Participants will receive daily intravitreal injections of KUS 121 or sham, which mimics an injection, from Day 1 through Day 3. Primary efficacy endpoint is the proportion of participants who gain 15 letters or more in BCVA compared with baseline and will be assessed at Week 12. Safety evaluation will continue until a 12-month follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
Participants will receive KUS121 high dose intravitreal (IVT) injection once on each of 3 consecutive days (Day 1 through Day 3).
Participants will receive KUS121 low dose intravitreal (IVT) injection once on each of 3 consecutive days (Day 1 through Day 3).
Participants will receive a sham procedure that mimics an intravitreal (IVT) injection once on each of 3 consecutive days (Day 1 through Day 3).
The Retina Partners
Encino, California, United States
Salehi Retina Institute, Inc
Huntington Beach, California, United States
Kaiser Permanente Oakland Med Ctr.
Oakland, California, United States
Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 12 compared to baseline
BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study. A higher ETDRS letter score means a better outcome (better visual acuity).
Time frame: At baseline, Week 12
Proportion of study eyes which achieve a gain of 15 ETDRS letters or more in BCVA at Week 4 compared to baseline
Time frame: At baseline, Week 4
Proportion of study eyes which achieve a gain of 0.3 Logarithm of Minimum Angle of Resolution (Log MAR) in BCVA at Week 12 compared to baseline
BCVA will be recorded using a Logarithm of the Minimum Angle of Resolution (LogMAR) scoring chart. A lower LogMAR score means a better outcome (better visual acuity).
Time frame: At baseline, Week 12
Proportion of study eyes which achieve a gain of 10 ETDRS letters or more in BCVA at Week 12 compared to baseline
Time frame: At baseline, Week 12
Mean change in BCVA (readable letters and Log MAR) at Week 12 compared to baseline
Time frame: At baseline, Week 12
Change in retinal thickness from baseline at Week 12 as measured by SD-OCT
Time frame: At baseline, Week 12
Change in the area of visual field from baseline to Week 12 as measured by Humphrey Field Analyzer
The Humphrey Visual Field Analyser test assesses the retina's ability to detect a light stimulus at specific points within the visual field. A higher score means a better outcome (better visual field).
Time frame: At baseline, Week 12
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Florida Retina Institute
Jacksonville, Florida, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Kresge Eye Institute/Wayne State University
Detroit, Michigan, United States
NYEE Infirmary of Mount Sinai
New York, New York, United States
UH Eye Institute
Cleveland, Ohio, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
...and 1 more locations
Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Time frame: From baseline through Week 48
Patients Reported Outcome
The results of National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) for each group at before, afterwards the disease onset and Week 12. A higher score means a better functioning (better patient-reported visual function).
Time frame: Up to Week 12