Diabetic Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
Intraretinal Fluid, Subretinal Fluid, Retinal Vein Occlusion, Diabetic Macular Edema
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.
Interventions
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.
DRUGKPI-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.
Sponsors
Kala Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 9 |
| 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
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. | 7 |
| Total | 16 |
Baseline characteristics
| Characteristic | KPI-121 1.0% Ophthalmic Suspension | Total | KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|---|
| Age, Customized Age (years) | 63.2 years STANDARD_DEVIATION 12.93 | 64.2 years STANDARD_DEVIATION 11.54 | 65.4 years STANDARD_DEVIATION 10.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 6 Participants |
| Region of Enrollment United States | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 9 | 2 / 7 |
| serious Total, serious adverse events | 0 / 9 | 1 / 7 |
Outcome results
Primary
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.
Time frame: Day 1 to Day 57
Population: Intent to treat- all subjects randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 1.0% Ophthalmic Suspension | Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) | -0.9 ETDRS letters | Standard Deviation 7.83 |
| KPI-121 0.25% Ophthalmic Suspension | Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) | -2.0 ETDRS letters | Standard Deviation 2 |
Primary
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)
Time frame: Day 1 to Day 57
Population: Intent to Treat (all randomized subjects) minus subjects in each treatment group that discontinued the study prior to this time point or otherwise did not have this assessment completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 1.0% Ophthalmic Suspension | Center Subfield Retinal Thickness by SD-OCT | -8.2 micrometers (μm) | Standard Deviation 52.37 |
| KPI-121 0.25% Ophthalmic Suspension | Center Subfield Retinal Thickness by SD-OCT | 4.8 micrometers (μm) | Standard Deviation 13.99 |
Primary
Investigator's Assessment of Leakage on the Fluorescein Angiogram
Change in leakage by investigator's assessment of the fluorescein angiogram
Time frame: Day 1 to Day 57
Population: Unable to analyze the FA data for efficacy. The efficacy variable defined in the protocol was the mean change from baseline in total area of fluorescein leakage and unfortunately the total area was not collected during the study.
Primary
Macular Volume by SD-OCT
Change in measurement (in microns) in macular volume as measured by Spectral Domain Optical Coherence Tomography (OCT)
Time frame: Day 1 to Day 57
Population: Intent to Treat (all randomized subjects) minus subjects in each treatment group that discontinued the study prior to this time point or otherwise did not have this assessment completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 1.0% Ophthalmic Suspension | Macular Volume by SD-OCT | -0.237 mm^3 | Standard Deviation 1.1607 |
| KPI-121 0.25% Ophthalmic Suspension | Macular Volume by SD-OCT | -0.377 mm^3 | Standard Deviation 0.819 |