Diabetic Macular EdemaPhase 2NCT05343156

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

A Phase 2 study testing Dexamethasone nanoparticles eye drops in people with Diabetic Macular Edema, run by Oculis at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetic Macular Edema
What is being tested?: Dexamethasone nanoparticles eye drops
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 1 siteDenmark
Study dates: 18 Sep 2017to 28 Mar 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
...

Who cannot join

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).
...

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Glostrup Hospital
Glostrup Municipality, 2600

Other trials in Denmark

About this study

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
Being tested: Dexamethasone nanoparticles eye drops

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05343156
Study group	Role	What they receive
DexNP Eye Drop	Experimental	The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. Receives: 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. Receives: Drug: Dexamethasone nanoparticles eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline & Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 201728 Mar 2019

First posted25 Apr 2022
Study start18 Sep 2017
Primary completion28 Mar 2019
Study completion28 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05343156
Sponsor's protocol ID: DX211
Status last verified: Jun 2022
First submitted: 18 Apr 2022
Last updated: 28 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
ClinicalTrials.gov ID: NCT05343156
Acronym / sponsor ID: DX211
Conditions: Diabetic Macular Edema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: OculisIndustry (pharma, biotech, devices)
Study start: 18 Sep 2017 (actual)
Primary completion: 28 Mar 2019 (actual)
Study completion: 28 Mar 2019 (actual)
First posted: 25 Apr 2022 (actual)
Results: Posted 2 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DexNP Eye Drop	Experimental	Drug: Dexamethasone nanoparticles eye dropsThe study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks.
Vehicle Eye Drop	Placebo comparator	Drug: Dexamethasone nanoparticles eye dropsThe study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 (3 listed)

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).
...

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexamethasone nanoparticles eye dropsDexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks	Drug	DexNP Eye Drop, Vehicle Eye Drop

Primary outcome

Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA)
Time frame: Baseline & Week 12
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.

Results and safety

Results posted to the registry on 2 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DexNP Eye Drop	99	91
Vehicle Eye Drop	45	42

Primary outcome: Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA)

Time frame: Baseline & Week 12. Least squares mean (70% Confidence Interval). Unit: ETDRS BCVA Letters

Measure	DexNP Eye Drop n = 99	Vehicle Eye Drop n = 45
Value	2.62 (1.831 to 3.403)	1.04 (-0.115 to 2.189)

Population analysed: Change from baseline to week 12 in Study Eye ETDRS BCVA Letters using Multiple Imputation (Intent-to-Treat Population)

Adverse events

Time frame: 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). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DexNP Eye Drop	11 of 99 (11.1%)	32 of 99 (32.3%)	2 of 99
Vehicle Eye Drop	1 of 45 (2.2%)	9 of 45 (20%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Larsen, MD study director

Glostrup University Hospital, Copenhagen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone nanoparticles eye drops in people with Diabetic Macular Edema, run by Oculis at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) (time frame: Baseline & Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05343156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.