Clinical trial NCT02245516: Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Vein Occlusion
Diabetic Macular Edema
Keywords: Intraretinal Fluid
Subretinal Fluid
Retinal Vein Occlusion
Diabetic Macular Edema
Lead sponsor: Kala Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)
timeFrame: Day 1 to Day 57
measure: Macular Volume by SD-OCT
timeFrame: Day 1 to Day 57
measure: Center Subfield Retinal Thickness by SD-OCT
timeFrame: Day 1 to Day 57
measure: Investigator's Assessment of Leakage on the Fluorescein Angiogram
timeFrame: Day 1 to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
References: