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

Not Applicable

Completed

• Conditions: Retinal Vein Occlusion; Diabetic Macular Edema
• Interventions: Drug: KPI-121 1.0% Ophthalmic Suspension; Drug: KPI-121 0.25% Ophthalmic Suspension

• Registration Number: NCT02245516
• Lead Sponsor: Kala Pharmaceuticals, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Disposition First Submitted: 2016-07-08
• Disposition First Submitted QC: 2016-07-08
• Disposition First Posted: 2016-07-12
• Results First Submitted: 2020-08-18
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Results First Posted: 2020-12-10
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KPI-121 1.0% Ophthalmic Suspension	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
KPI-121 0.25% Ophthalmic Suspension	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

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)	Day 1 to Day 57	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.
Investigator's Assessment of Leakage on the Fluorescein Angiogram	Day 1 to Day 57	Change in leakage by investigator's assessment of the fluorescein angiogram
Macular Volume by SD-OCT	Day 1 to Day 57	Change in measurement (in microns) in macular volume as measured by Spectral Domain Optical Coherence Tomography (OCT)
Center Subfield Retinal Thickness by SD-OCT	Day 1 to Day 57	Change in measurement (in microns) in the central subfield retinal thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)

Trial Locations

Locations (2)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States