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

NCT02245516 | Completed Results

• 1 other identifier: KPI-121-C-004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Retinal Vein Occlusion; Diabetic Macular Edema

Keywords

Intraretinal Fluid; Subretinal Fluid; Retinal Vein Occlusion; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

KPI-121 0.25% Ophthalmic Suspension

ACTIVE COMPARATOR

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 1.0% Ophthalmic Suspension

ACTIVE COMPARATOR

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

Interventions

KPI-121 0.25% Ophthalmic Suspension DRUG

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.

Also known as: Loteprednol etabonate 0.25%

KPI-121 0.25% Ophthalmic Suspension

KPI-121 1.0% Ophthalmic Suspension DRUG

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.

Also known as: Loteprednol etabonate 1.0%

KPI-121 1.0% Ophthalmic Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema at Screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.: lead

Study Sites (2)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: VP, Clinical Development
• Organization: Kala Pharmaceuticals Inc

results004@kalarx.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 19, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-12

Locations

US (2)