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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; Retinal Vein Occlusion
• Intervention / Treatment: Drug: KPI-121 0.25% Ophthalmic Suspension; Drug: KPI-121 1.0% Ophthalmic Suspension

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KPI-121 0.25% Ophthalmic Suspension; 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; 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.; Other Names: Loteprednol etabonate 0.25%
Active Comparator: KPI-121 1.0% Ophthalmic Suspension; 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; 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.; Other Names: Loteprednol etabonate 1.0%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kala Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Retinal Vein Occlusion; Subretinal Fluid; Intraretinal Fluid
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: KPI-121-C-004