Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema

Study Overview
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Brief Summary
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The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25% ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Detailed Description
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This is a multicenter, randomized, single-masked study evaluating the safety and effect of topical ocular administration of either KPI-121 0.25% ophthalmic suspension or KPI-121 1.0% ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Official Title
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An Exploratory, Multi-Center, Randomized, Single-Masked Study Evaluating the Effect of KPI-121 on Intraretinal or Subretinal Fluid Secondary to Retinal Vein Occlusion or Diabetic Macular Edema

Conditions
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Retinal Vein Occlusion, Diabetic Macular Edema

Intervention / Treatment
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* Drug: KPI-121 0.25% Ophthalmic Suspension
* Drug: KPI-121 1.0% Ophthalmic Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema at Screening Exclusion Criteria: Treatment with topical, intravitreal injection, posterior sub-Tenon's, or periocular corticosteroids within 120 days prior to Visit 1 and for the duration of the study History of uncontrolled glaucoma, IOP over 21 mmHg at Visit 1, or are being treated for glaucoma in the study eye Any significant ocular disease that could compromise vision in the study eye (including ongoing ocular infection, wet age-related macular degeneration, myopic degeneration with active subfoveal choroidal neovascularization) Known hypersensitivity or contraindication to the investigational product(s) or their components Diagnosis of severe/serious ocular condition that in the judgment of the Investigator could confound study assessments or limit compliance; or severe/serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments or limit compliance Exposed to an investigational drug within 30 days prior to Visit 1 and for the duration of the study In the opinion of the Investigator or study coordinator, an unwillingness or inability to comply with the study protocol or inability to successfully instill eye drops

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KPI-121 0.25% Ophthalmic Suspension<br>KPI-121 0.25% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema | Drug: KPI-121 0.25% Ophthalmic Suspension<br>* KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.<br>* Other names: Loteprednol etabonate 0.25%;|
| Active Comparator: KPI-121 1.0% Ophthalmic Suspension<br>KPI-121 1.0% Ophthalmic Suspension dosed QID for 4 weeks in subjects with Retinal Vein Occlusion or Diabetic Macular Edema | Drug: KPI-121 1.0% Ophthalmic Suspension<br>* KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.<br>* Other names: Loteprednol etabonate 1.0%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) | Best Corrected Visual Acuity (BCVA) was measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. More letters read correctly results in a higher letter score, which represents better visual acuity. | Day 1 to Day 57 | 
| Macular Volume by SD-OCT | Change in measurement (in microns) in macular volume as measured by Spectral Domain Optical Coherence Tomography (OCT) | Day 1 to Day 57 | 
| Center Subfield Retinal Thickness by SD-OCT | Change in measurement (in microns) in the central subfield retinal thickness as measured by Spectral Domain Optical Coherence Tomography (OCT) | Day 1 to Day 57 | 
| Investigator's Assessment of Leakage on the Fluorescein Angiogram | Change in leakage by investigator's assessment of the fluorescein angiogram | Day 1 to Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraretinal Fluid, Subretinal Fluid, Retinal Vein Occlusion, Diabetic Macular Edema