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

NCT ID: NCT05343156

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2019-03-28

Brief Summary

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DexNP Eye Drop

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

Group Type: EXPERIMENTAL

Dexamethasone nanoparticles eye drops

Intervention Type: DRUG

DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks

Vehicle Eye Drop

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

Group Type: PLACEBO_COMPARATOR

Dexamethasone nanoparticles eye drops

Intervention Type: DRUG

DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks

Interventions

Dexamethasone nanoparticles eye drops

DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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;

...

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).

...

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oculis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Larsen, MD

Role: STUDY_DIRECTOR

Glostrup University Hospital, Copenhagen

Locations

Glostrup Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DX211

Identifier Type: -

Identifier Source: org_study_id