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

NCT05343156 | Completed Phase 2 Results FDA Drug

• 1 other identifier: DX211
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DexNP Eye Drop

EXPERIMENTAL

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

Drug: Dexamethasone nanoparticles eye drops

Vehicle Eye Drop

PLACEBO COMPARATOR

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

Drug: Dexamethasone nanoparticles eye drops

Interventions

Dexamethasone nanoparticles eye drops DRUG

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

DexNP Eye Drop; Vehicle Eye Drop

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oculis: lead

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Results Point of Contact

• Title: Bastian Dehmel, Chief Development Officer
• Organization: Oculis SA

bastian.dehmel@culis.com

0041 21 711 39 70

Study Officials

• Michael Larsen, MD

  Glostrup University Hospital, Copenhagen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: September 18, 2017
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: June 28, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-06

Locations

DK (1)