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Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow release drug capsules surgically implanted in the eyes run the risk of surgical complications including infections, hemorrhages and cataracts and place a huge demand on eye care resources significantly increase the risk of cardiovascular events and death.
A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to treat DME and other retinal diseases would circumvent most of these problems.
A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial clinical testing has shown the potential for this technology to increase the drug concentration in the eye tissues including the retina and therefore treat retinal diseases like DME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DexNP Eye Drop | Experimental | The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. |
|
| Vehicle Eye Drop | Placebo Comparator | The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone nanoparticles eye drops | Drug | DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) | The primary efficacy endpoint was summarized by treatment group using descriptive statistics, including 70%, 90% and 95% confidence intervals (CIs). Change from baseline to Week 12 is also summarised by treatment group. The primary analysis of the primary endpoint employed a linear model with change from baseline ETDRS BCVA letters as the response, baseline ETDRS BCVA letters as a covariate, and treatment as a main effect factor, using the ITT population and with multiple imputation pattern mixture model techniques used to impute missing data. | Baseline & Week 12 |
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Key Inclusion Criteria:
Had DME of less than 3 years duration since diagnosis with presence of intraretinal and/or subretinal fluid in the study eye, with CMT of ≥ 310 µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator).
Had definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator's clinical evaluation and by SD-OCT;
...
Key Exclusion Criteria:
Had macular edema considered to be due to a cause other than DME;
Had a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
...
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| Name | Affiliation | Role |
|---|---|---|
| Michael Larsen, MD | Glostrup University Hospital, Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup Hospital | Glostrup Municipality | 2600 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | DexNP Eye Drop | The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks |
| FG001 | Vehicle Eye Drop | The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DexNP Eye Drop | The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks |
| BG001 | Vehicle Eye Drop |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) | The primary efficacy endpoint was summarized by treatment group using descriptive statistics, including 70%, 90% and 95% confidence intervals (CIs). Change from baseline to Week 12 is also summarised by treatment group. The primary analysis of the primary endpoint employed a linear model with change from baseline ETDRS BCVA letters as the response, baseline ETDRS BCVA letters as a covariate, and treatment as a main effect factor, using the ITT population and with multiple imputation pattern mixture model techniques used to impute missing data. | Change from baseline to week 12 in Study Eye ETDRS BCVA Letters using Multiple Imputation (Intent-to-Treat Population) | Posted | Least Squares Mean | 70% Confidence Interval | ETDRS BCVA Letters | Baseline & Week 12 |
|
Subjects were monitored for safety on all study visits. Assessment of AEs, including definition of seriousness, severity and causality was performed at each visit : day 1 (visit 2), week 2 (visit 3), week 4 (visit 4), week 8 (visit 5) , week 12 (visit 6) and week 16 (visit 7)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DexNP Eye Drop | The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | MedDRA Version 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bastian Dehmel, Chief Development Officer | Oculis SA | 0041 21 711 39 70 | bastian.dehmel@culis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2017 | May 5, 2022 | Prot_SAP_000.pdf |
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The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.
Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.
Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks
| OG001 | Vehicle Eye Drop | The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks |
|
|
| 2 |
| 99 |
| 11 |
| 99 |
| 32 |
| 99 |
| EG001 | Vehicle Eye Drop | The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks. Dexamethasone nanoparticles eye drops: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks | 0 | 45 | 1 | 45 | 9 | 45 |
| Cardiac failure | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Endocrine disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| diabetic ulcer | Endocrine disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Blood glucose fluctuation | Investigations | MedDRA Version 21.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Cataract subcapscular | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| conjunctival hemorrhage | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Diabetic retinal edema | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| erythema of eyelid | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| eyelid ptosis | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| glaucoma | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| noninfective conjunctivitis | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Ocular hyperemia | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| photophobia | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| posterior capsule opacification | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| conjunctival hyperemia | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| conjunctivitis | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| corneal edema | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| eye infection bacterial | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| eye pruritus | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| foreign body sensation in eyes | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| keratopathy | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| retinal pigment epitheliopathy | Eye disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| conjunctivitis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
| eye infection bacterial | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
|
Investigator agrees not to publish/present the results until such time as the aggregate study results are published. After such time, Investigator may publish the results in accordance with the following: Investigator shall submit to Sponsor any such proposed publication/presentation resulting from or relating to the Study at least 60 days prior to the submission for publication. Sponsor may require the delay of publication/presentation for an additional period of time not to exceed 120 days.