Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema

Oculis

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Dexamethasone nanoparticles eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT05343156

DX211

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. 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).

2. 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:

1. Had macular edema considered to be due to a cause other than DME;

2. 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).

   ...

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups, including a placebo group

DexNP Eye Drop

Experimental group

Description:

The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.

Treatment:

Drug: Dexamethasone nanoparticles eye drops

Vehicle Eye Drop

Placebo Comparator group

Description:

The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.

Treatment:

Drug: Dexamethasone nanoparticles eye drops