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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02245516
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Retinal Vein Occlusion
Diabetic Macular Edema
Interventions Drug: KPI-121 0.25% Ophthalmic Suspension
Drug: KPI-121 1.0% Ophthalmic Suspension
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 9 7
Completed 9 4
Not Completed 0 3
Arm/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 9 7 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age (years) Number Analyzed 9 participants 7 participants 16 participants
63.2  (12.93) 65.4  (10.34) 64.2  (11.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 16 participants
Female
2
  22.2%
2
  28.6%
4
  25.0%
Male
7
  77.8%
5
  71.4%
12
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  33.3%
1
  14.3%
4
  25.0%
White
6
  66.7%
6
  85.7%
12
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants 7 participants 16 participants
9
 100.0%
7
 100.0%
16
 100.0%
1.Primary Outcome
Title Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat- all subjects randomized
Arm/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 9 7
Mean (Standard Deviation)
Unit of Measure: ETDRS letters
-0.9  (7.83) -2.0  (2.00)
2.Primary Outcome
Title Macular Volume by SD-OCT
Hide Description Change in measurement (in microns) in macular volume as measured by Spectral Domain Optical Coherence Tomography (OCT)
Time Frame Day 1 to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: mm^3
-0.237  (1.1607) -0.377  (0.8190)
3.Primary Outcome
Title Center Subfield Retinal Thickness by SD-OCT
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: micrometers (μm)
-8.2  (52.37) 4.8  (13.99)
4.Primary Outcome
Title Investigator's Assessment of Leakage on the Fluorescein Angiogram
Hide Description Change in leakage by investigator's assessment of the fluorescein angiogram
Time Frame Day 1 to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from the time a subjects signed the informed consent until they exited the study at the end of Visit 5 (up to 57 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Hide Arm/Group Description

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.

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.

All-Cause Mortality
KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      1/7 (14.29%)    
General disorders     
generalized weakness  1 [1]  0/9 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
1 Subject had a non-ocular SAE hospitalization of generalized weakness starting on Day 7 resolved Day 28. It was mild in severity, was not considered by the Investigator to be related to study treatment and the subject discontinued from the trial.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
KPI-121 1.0% Ophthalmic Suspension KPI-121 0.25% Ophthalmic Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      2/7 (28.57%)    
Eye disorders     
Increase in floaters   1/9 (11.11%)  1 0/7 (0.00%)  0
Pain   1/9 (11.11%)  1 0/7 (0.00%)  0
Punctate Epithelial Erosions   1/9 (11.11%)  1 0/7 (0.00%)  0
Soreness   0/9 (0.00%)  0 1/7 (14.29%)  1
General disorders     
generalized weakness   0/9 (0.00%)  0 1/7 (14.29%)  1
Worsening of Hypercholesterolemia   0/9 (0.00%)  0 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No submission for publication or public disclosure will be made by the PI until after the publication of the results of the multi-center clinical trial by the Sponsor. Thereafter, PI shall provide KALA with an advance copy of any proposed publication or public disclosure at least sixty (60) days prior to the planned date of submission or disclosure and KALA shall have forty-five (45) days from the date of its receipt to recommend changes.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP, Clinical Development
Organization: Kala Pharmaceuticals Inc
EMail: results004@kalarx.com
Layout table for additonal information
Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02245516    
Other Study ID Numbers: KPI-121-C-004
First Submitted: September 4, 2014
First Posted: September 19, 2014
Results First Submitted: August 18, 2020
Results First Posted: December 10, 2020
Last Update Posted: December 10, 2020