Dexamethasone Eye Drops for Diabetic Macular Edema

Not currently recruiting at 63 trial locations

Overseen By Oculis Study Leader

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Oculis

Disqualifiers: Macular ischemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 58

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of eye drops containing dexamethasone for individuals with diabetic macular edema (DME), a condition where fluid accumulates in the eye, impairing vision. The study compares these eye drops to a placebo to determine their ability to reduce swelling and improve sight. Individuals with DME who have been diagnosed with diabetes and are experiencing fluid in their eyes might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexamethasone eye drops, such as OCS-01, are generally safe for use. Studies have found that OCS-01 is effective and safe for treating conditions like diabetic macular edema (DME). In one study, patients using OCS-01 experienced fewer side effects than those not using it. Another study demonstrated that these eye drops were also safe for reducing inflammation and pain after cataract surgery. While mild side effects, such as eye irritation or discomfort, can occur, they are uncommon. Overall, evidence suggests that OCS-01 eye drops are safe for treating DME. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

Unlike the standard treatments for diabetic macular edema, which often involve injections directly into the eye, OCS-01 is an eye drop containing dexamethasone, a powerful anti-inflammatory steroid. This new delivery method could make treatment much easier and more comfortable for patients. Researchers are excited because OCS-01 has the potential to effectively reduce swelling and improve vision without the need for invasive procedures. This could be a game-changer for people with diabetic macular edema, offering a simpler and potentially less risky option.

What evidence suggests that OCS-01 (dexamethasone) might be an effective treatment for Diabetic Macular Edema?

Research shows that OCS-01, an eye drop containing dexamethasone, effectively treats diabetic macular edema (DME). Studies have found that it significantly improves vision and reduces retinal swelling. This trial will compare OCS-01 with a placebo vehicle control. In previous tests, OCS-01 outperformed a placebo in reducing swelling in the central retina, indicating a positive sign for managing the condition. These findings suggest that OCS-01 could be a promising treatment option for those with DME. ^{1 2 6 7 8}

Who Is on the Research Team?

Veeral S Sheth, MD

Principal Investigator

University Retina - Lemont

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 or type 2 diabetes who have diabetic macular edema (DME), a condition causing swelling in the retina. Participants must have an HbA1c of ≤12.0% and retinal swelling confirmed by specific eye scans. It's not for those whose DME has other causes, significant macular ischemia, or vision loss from non-DME issues.

Inclusion Criteria

Have a signed informed consent form before any study-specific procedures are performed

I have diabetes with an HbA1c level of 12.0% or lower.

Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center)

Exclusion Criteria

I have a history of severe eye blood flow problems that affect my vision.

My macular edema is not due to diabetic macular edema.

My vision loss is not due to diabetic macular edema but other eye conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

To select a dosing regimen for OCS-01 and evaluate efficacy and safety compared to Vehicle at Week 12

12 weeks

Visits at baseline, Week 6, and Week 12

Stage 2 Treatment

Evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52

40 weeks

Regular visits up to Week 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OCS-01 (dexamethasone)
• Vehicle

Trial Overview The study tests OCS-01 (dexamethasone) eye drops against a placebo (vehicle) to see if they're safe and effective for treating DME. Patients will be randomly assigned to receive either the active treatment or placebo.

How Is the Trial Designed?

Group I: OCS-01 Experimental Treatment 1 Intervention

dexamethasone ophthalmic suspension,1.5% \[15 mg/ mL\]

Group II: Vehicle Vehicle Placebo Group 1 Intervention

Placebo is a Vehicle ophthalmic suspension of OCS-01

OCS-01 (dexamethasone) is already approved in United States, European Union for the following indications:

Approved in United States as Dexamethasone for:

• Uveitis
• Uveitis - Posterior
• Macular Edema
• Conjunctivitis
• Conjunctivitis - Allergic
• Iritis
• Cyclitis
• Keratitis
• Postoperative Ocular Inflammation

Approved in European Union as Dexamethasone for:

• Uveitis
• Uveitis - Posterior
• Macular Edema
• Conjunctivitis
• Conjunctivitis - Allergic
• Iritis
• Cyclitis
• Keratitis
• Postoperative Ocular Inflammation

Who Is Running the Clinical Trial?

Oculis

Lead Sponsor

Trials

9

Recruited

1,700+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Published Research Related to This Trial

Topical 1.5% dexamethasone aqueous eye drops with cyclodextrin microparticles were found to be safe and well-tolerated in a pilot study involving 19 patients with diabetic macular edema (DME), showing no severe adverse effects.

The treatment significantly improved visual acuity and reduced central macular thickness after 4 weeks, with 74% of patients experiencing improved vision and 63% showing a decrease in macular thickness by more than 10%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema. Tanito, M., Hara, K., Takai, Y., et al.[2013]

The study found that 0.7% dexamethasone-cyclodextrin eye drops, applied once daily, are more effective in controlling postoperative inflammation after cataract surgery compared to 0.1% dexamethasone sodium phosphate eye drops applied three times daily, based on measurements taken over 21 days.

Both treatments resulted in normal visual acuity and lower intraocular pressure three weeks post-surgery, but the once-daily regimen may be particularly beneficial for elderly patients who have difficulty administering multiple doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. Saari, KM., Nelimarkka, L., Ahola, V., et al.[2018]

Topical 1.5% dexamethasone γ-cyclodextrin nanoparticle eye drops (DexNP) significantly improved visual acuity and reduced central macular thickness in patients with diabetic macular edema (DME), showing similar efficacy to a single injection of triamcinolone acetonide.

While both treatments affected serum cortisol levels, DexNP caused a modest increase in intraocular pressure (IOP), which normalized after stopping the treatment, indicating a potential safety concern that requires monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical dexamethasone γ-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema. Ohira, A., Hara, K., Jóhannesson, G., et al.[2015]

In a pilot study involving 8 eyes with non-infectious uveitic macular oedema and vitritis, 1.5% dexamethasone nanoparticle drops significantly improved best corrected visual acuity (BCVA) and resolved macular oedema in all cases during the 12-week follow-up.

While the treatment was generally safe, with most eyes showing improvement, one case experienced elevated intraocular pressure and another had cataract progression, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical dexamethasone-cyclodextrin nanoparticle eye drops for non-infectious Uveitic macular oedema and vitritis - a pilot study. Shulman, S., Jóhannesson, G., Stefánsson, E., et al.[2023]

Topical dexamethasone ophthalmic suspension OCS-01 significantly reduced central macular thickness in patients with diabetic macular edema (DME) compared to a vehicle, with a mean decrease of -53.6 μm versus -16.8 μm after 12 weeks (p = 0.0115).

While the improvement in visual acuity (measured by ETDRS letter score) was not statistically significant overall, patients with lower baseline vision (≤65 letters) showed a notable improvement of +3.8 letters with OCS-01 compared to +0.9 letters with the vehicle, suggesting targeted efficacy in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical treatment of diabetic macular edema using dexamethasone ophthalmic suspension: A randomized, double-masked, vehicle-controlled study. Stefansson, E., Loftsson, T., Larsen, M., et al.[2023]

A new non-invasive eye drop formulation of dexamethasone combined with gamma-cyclodextrin successfully delivered therapeutic levels of the steroid to the retina in rabbits, achieving concentrations comparable to those from traditional intravitreal injections.

The formulation was stable for 7 months and well tolerated, showing no short-term side effects, indicating a promising alternative to invasive injection methods for retinal steroid delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyclodextrin microparticles for drug delivery to the posterior segment of the eye: aqueous dexamethasone eye drops. Loftsson, T., Hreinsdóttir, D., Stefánsson, E.[2013]

Topical eye drops using γ-cyclodextrin (γCD)-based nanoparticles can effectively deliver therapeutic drugs like dorzolamide and dexamethasone to both the anterior and posterior segments of the eye, potentially reducing the need for invasive treatments.

Early human studies indicate that dorzolamide/γCD eye drops can lower intraocular pressure as effectively as traditional drops but require less frequent application, while pilot studies suggest dexamethasone/γCD drops may be beneficial for various eye conditions, highlighting their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous eye drops containing drug/cyclodextrin nanoparticles deliver therapeutic drug concentrations to both anterior and posterior segment. Loftsson, T., Stefánsson, E.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26201996/

Topical dexamethasone γ-cyclodextrin nanoparticle eye ... Conclusion: Topical DexNP significantly improve visual acuity and decrease macular thickness in patients with DME. The effect is similar to that from subtenon ...

2. investors.oculis.com investors.oculis.com/news-releases/news-release-details/oculis-present-clinical-trial-results-diabetic-macular-edema-and

Oculis to Present Clinical Trial Results in Diabetic Macular ... The results highlight the potential of OCS-01 to benefit various DME patient profiles, including phakic and pseudophakic patients, as well as ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05343156

Efficacy and Safety of Dexamethasone Nanoparticles Eye ... 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 ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/aos.15215

Topical treatment of diabetic macular edema using ... Topical OCS-01 was significantly more effective than vehicle in improving central macular thickness in patients with DME.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06172257

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in ... The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in ...

6. oculis.com oculis.com/clinical-trials/phase-2-efficacy-and-safety-of-dexamethasone-nanoparticles-ocs-01-eye-drops-in-diabetic-macular-edema/

Efficacy and Safety of Dexamethasone Nanoparticles (OCS ... Our Areas of Focus · Diabetic Macular Edema I OCS-01 · Post Ocular Surgery I OCS-01 · Dry Eye Disease I OCS-02 · Uveitis ׀ OCS-02 · Acute Optic Neuritis I OCS-05.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291822003782

OCS-01 (Novel Topical Dexamethasone Formulation) in ... OCS-01 once daily and BID were more effective than vehicle and well tolerated in the treatment of inflammation and pain after cataract surgery.

8. delta.larvol.com delta.larvol.com/Products/?ProductId=67c6cc3b-b3e5-41ed-88a4-a06e93687554

dexamethasone cyclodextrin nanoparticle ophthalmic ... ... OCS-01 OPTIREACH® Topical Dexamethasone Eye Drops in Subjects with Diabetic Macular Edema (DME): Efficacy and Safety Findings (ARVO 2024) - "The study ...