The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01. Macular edema is a condition in which there is collection of fluid (edema) in the back of the eye (Macula) and it can lead to severe loss of vision. Among other causes, macular edema can happen because of a disease of the eye called Uveitis, and also after eye surgery. Treatment of macular edema remains a challenge as the condition may persist for several months and may lead to irreversible changes in the eye and poor vision. In the LEOPARD study the investigators wish to see how safe is the study drug (OCS-01) and how well it works, in resolving the fluid collection in the eye in patients with Uveitis or in patients who have had eye surgery. Participants will undergo detailed eye exam, and record their eye and medical history to see what their disease status is and if they can be included in the study based on the study criteria. If included, they will take the study drug OCS-01 in different doses for 24 weeks. During the study period, they will have regular eye exams to ensure their safety and to assess the usefulness of the study drug.
LEOPARD is a prospective, multi-center, single masked, randomized, controlled, study. At least 24 eligible subjects (12 with Uveitic macular edema and 12 with Post surgical macular edema) are to be enrolled in the study. There will be at least 5 sites and the total treatment period is 24 weeks. The study will consist of 4 phases: Screening Phase, Loading Phase, Treatment Phase and Follow-up Phase. Subjects will receive their assigned treatments until week 04, get randomized into groups and continue their assigned treatments until week 12. Primary endpoint assessments will be performed at week 12. From week 12 to week 24, if there is still edema as demonstrated on OCT, subjects will receive treatment based on the retreatment criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
One drop of OCS-01 eye drops, 3-6 times daily. Dosing frequency will depend on the phase of the study.
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
Stein Eye Institute at UCLA
Los Angeles, California, United States
Byers Eye Institute at Stanford
Palo Alto, California, United States
Massachusetts Eye Research and Surgery Institution
Boston, Massachusetts, United States
Erie Retina Research
Erie, Pennsylvania, United States
Valley Retina Institute P.A
McAllen, Texas, United States
Texas Retina Associates
Plano, Texas, United States
Central Subfield Thickness
Mean change in central subfield thickness (CST) on optical coherence tomography (OCT) at week 12 compared to baseline.
Time frame: Baseline to 12 weeks
Visual Acuity
Mean change in early treatment of diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score at week 12
Time frame: Baseline to 12 weeks
Change in visual acuity
Mean change in ETDRS BCVA letters at weeks 2, 4, 6, 8, 16, 20 and 24 compared to baseline.
Time frame: Baseline to 24 weeks
Change in visual acuity
The percentage of subjects who gain ≥10 or ≥15 ETDRS letters at week 12 and 24 compared to baseline.
Time frame: Week 12 and 24
Central Subfield Thickness
Mean change in CST as assessed by SD-OCT at weeks 2, 4, 6, 8, 16, 20, 24 compared to baseline.
Time frame: Baseline to week 24
Visual function and quality of life
Improvement in quality of life as assessed by National Eye Institute Visual Function Questionnaire (NEI VFQ-25) at Week 12, and 24 compared to baseline.
Time frame: Baseline, week 12 and week 24
Change in macular leakage
Percentage of subjects showing change in macular leakage on fluorescein angiography (FA) at week 12 and 24 compared to baseline
Time frame: Baseline, week 12 and 24 weeks
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