N/A
Completed N=16
Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema
Source: ClinicalTrials.gov NCT02245516 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Dec 2020
Primary outcomePrimary: Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) — -0.9; -2.0 ETDRS letters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) |
-0.9; -2.0 | — |
| PRIMARY Macular Volume by SD-OCT |
-0.237; -0.377 | — |
| PRIMARY Center Subfield Retinal Thickness by SD-OCT |
-8.2; 4.8 | — |
| PRIMARY Investigator's Assessment of Leakage on the Fluorescein Angiogram |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT02245516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.