Trial · NCT02245516
Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema
NCT02245516, Not applicable, Completed, Kala Pharmaceuticals, Inc.; results first posted 2020-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema. Trials, record NCT02245516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02245516
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema
- NCT number
- NCT02245516
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 16 participants, actual
- Lead sponsor
- Kala Pharmaceuticals, Inc.
- Conditions
- Retinal Vein Occlusion, Diabetic Macular Edema
- Interventions
- KPI-121 0.25% Ophthalmic Suspension, KPI-121 1.0% Ophthalmic Suspension
- First posted
- 2014-09-19
- Last updated
- 2020-12-10
- Results first posted
- 2020-12-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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) |
| Primary | 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) |
| Primary | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) | Day 1 to Day 57 | Intent to treat- all subjects randomized | ETDRS letters | MEAN |
| PRIMARY | Macular Volume by SD-OCT | Day 1 to Day 57 | 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 | mm^3 | MEAN |
| PRIMARY | Center Subfield Retinal Thickness by SD-OCT | Day 1 to Day 57 | 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 | micrometers (μm) | MEAN |
| PRIMARY | Investigator's Assessment of Leakage on the Fluorescein Angiogram | Day 1 to Day 57 | 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. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) | KPI-121 1.0% Ophthalmic Suspension | -0.9 | Standard Deviation 7.83 | ETDRS letters | |
| Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) | KPI-121 0.25% Ophthalmic Suspension | -2.0 | Standard Deviation 2.00 | ETDRS letters | |
| Macular Volume by SD-OCT | KPI-121 1.0% Ophthalmic Suspension | -0.237 | Standard Deviation 1.1607 | mm^3 | |
| Macular Volume by SD-OCT | KPI-121 0.25% Ophthalmic Suspension | -0.377 | Standard Deviation 0.8190 | mm^3 | |
| Center Subfield Retinal Thickness by SD-OCT | KPI-121 1.0% Ophthalmic Suspension | -8.2 | Standard Deviation 52.37 | micrometers (μm) | |
| Center Subfield Retinal Thickness by SD-OCT | KPI-121 0.25% Ophthalmic Suspension | 4.8 | Standard Deviation 13.99 | micrometers (μm) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KPI-121 1.0% Ophthalmic Suspension | 9 | |
| Overall Study | STARTED | KPI-121 0.25% Ophthalmic Suspension | 7 | |
| Overall Study | COMPLETED | KPI-121 1.0% Ophthalmic Suspension | 9 | |
| Overall Study | COMPLETED | KPI-121 0.25% Ophthalmic Suspension | 4 | |
| Overall Study | NOT COMPLETED | KPI-121 1.0% Ophthalmic Suspension | 0 | |
| Overall Study | NOT COMPLETED | KPI-121 0.25% Ophthalmic Suspension | 3 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increase in floaters | Eye disorders | KPI-121 1.0% Ophthalmic Suspension | 1 | 9 | 1 |
| other | Increase in floaters | Eye disorders | KPI-121 0.25% Ophthalmic Suspension | 0 | 7 | 0 |
| other | Pain | Eye disorders | KPI-121 1.0% Ophthalmic Suspension | 1 | 9 | 1 |
| other | Pain | Eye disorders | KPI-121 0.25% Ophthalmic Suspension | 0 | 7 | 0 |
| other | Punctate Epithelial Erosions | Eye disorders | KPI-121 1.0% Ophthalmic Suspension | 1 | 9 | 1 |
| other | Punctate Epithelial Erosions | Eye disorders | KPI-121 0.25% Ophthalmic Suspension | 0 | 7 | 0 |
| other | generalized weakness | General disorders | KPI-121 1.0% Ophthalmic Suspension | 0 | 9 | 0 |
| other | generalized weakness | General disorders | KPI-121 0.25% Ophthalmic Suspension | 1 | 7 | 1 |
| other | Soreness | Eye disorders | KPI-121 1.0% Ophthalmic Suspension | 0 | 9 | 0 |
| other | Soreness | Eye disorders | KPI-121 0.25% Ophthalmic Suspension | 1 | 7 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KPI-121 1.0% Ophthalmic Suspension | ||
| Total, all-cause mortality | KPI-121 0.25% Ophthalmic Suspension | ||
| Total, other adverse events | KPI-121 1.0% Ophthalmic Suspension | 3 | 9 |
| Total, other adverse events | KPI-121 0.25% Ophthalmic Suspension | 2 | 7 |
| Total, serious adverse events | KPI-121 1.0% Ophthalmic Suspension | 0 | 9 |
| Total, serious adverse events | KPI-121 0.25% Ophthalmic Suspension | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| KPI-121 1.0% Ophthalmic Suspension vs KPI-121 0.25% Ophthalmic Suspension: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02245516
GET https://conductscience.org/api/trials/v1/NCT02245516/registered