Dexamethasone Eye Drops for Diabetic Macular Edema

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Veeral S Sheth, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Oculis

Disqualifiers: Macular ischemia, others

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).

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.

What data supports the effectiveness of the drug OCS-01 (dexamethasone) for diabetic macular edema?

Research shows that dexamethasone eye drops, specifically in the form of γ-cyclodextrin nanoparticles, can improve vision and reduce swelling in the eyes of people with diabetic macular edema. ^{1 2 3 4 5}

Is it safe to use dexamethasone eye drops for diabetic macular edema?

Research shows that dexamethasone eye drops, including those with cyclodextrin microparticles, are generally well tolerated in humans and animals, with no visible short-term side effects reported in studies. ^{1 2 4 5 6}

How is the drug OCS-01 (dexamethasone eye drops) different from other treatments for diabetic macular edema?

OCS-01 is unique because it uses a non-invasive eye drop method to deliver dexamethasone, a steroid, to the back of the eye, potentially replacing the need for injections. This eye drop formulation uses cyclodextrin nanoparticles to effectively reach both the front and back parts of the eye, offering a safer and more convenient option for patients. ^{1 2 3 6 7}

Research Team

Veeral S Sheth, MD

Principal Investigator

University Retina - Lemont

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• OCS-01 (dexamethasone) (Corticosteroid)
• Vehicle (Drug)

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.

Participant Groups

Group I: OCS-01 Experimental Treatment 1 Intervention

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

Group II: Vehicle placebo arm Placebo Group 1 Intervention

Vehicle ophthalmic suspension

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+

Costa Panagos

Syneos Health

Chief Executive Officer

Bachelor's degree in a relevant field (specific details not available)

Suma Ramadas

Syneos Health

Chief Medical Officer since 2022

PhD in a relevant field (specific details not available)

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Topical dexamethasone γ-cyclodextrin nanoparticle eye drops increase visual acuity and decrease macular thickness in diabetic macular oedema. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Topical dexamethasone-cyclodextrin nanoparticle eye drops for non-infectious Uveitic macular oedema and vitritis - a pilot study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Topical treatment of diabetic macular edema using dexamethasone ophthalmic suspension: A randomized, double-masked, vehicle-controlled study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Cyclodextrin microparticles for drug delivery to the posterior segment of the eye: aqueous dexamethasone eye drops. [2013]

7. England pubmed.ncbi.nlm.nih.gov

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