Dexamethasone Eye Drops for Diabetic Macular Edema

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by David S. Boyer, 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.

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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.

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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.

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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

Participant Groups

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.

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

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Oculis Investigative Site Beverly Hills, CA

Oculis Investigative Site - Retina Vitreous Associates Medical Group Beverly Hills, CA

Oculis Investigative Site: University Retina - Lemont Lemont, IL

Who Is Running the Clinical Trial?

Oculis Lead Sponsor

ICON plc Industry Sponsor

Syneos Health Collaborator

References

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

Topical dexamethasone-cyclodextrin microparticle eye drops for diabetic macular edema. [2013] To test the safety and efficacy of topical 1.5% dexamethasone aqueous eye drops with cyclodextrin microparticles for diabetic macular edema (DME).

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] To compare in a randomized, controlled trial topical 1.5% dexamethasone γ-cyclodextrin nanoparticle eye drops (DexNP) with posterior subtenon injection of triamcinolone acetonide in diabetic macular oedema (DME).

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

Comparison of topical 0.7% dexamethasone-cyclodextrin with 0.1% dexamethasone sodium phosphate for postcataract inflammation. [2018] To compare 0.7% dexamethasone-cyclodextrin aqueous eye drop solution applied once daily with 0.1% dexamethasone sodium phosphate eye drops applied three times a day for the control of postoperative inflammation after cataract surgery.

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] To evaluate the safety and efficacy of 1.5% dexamethasone nanoparticle (DexNP) drops in eyes with non-infectious uveitic macular oedema and vitritis.

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] To evaluate topical dexamethasone ophthalmic suspension OCS-01 (Oculis SA, Lausanne, Switzerland) in diabetic macular edema (DME).

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

Cyclodextrin microparticles for drug delivery to the posterior segment of the eye: aqueous dexamethasone eye drops. [2013] Delivery of steroids to the retina is currently undertaken with invasive injections into the vitreous cavity. This paper describes a non-invasive method to deliver steroids in therapeutic levels to the retina in rabbits. Dexamethasone was formulated as somewhat water-soluble dexamethasone/gamma-cyclodextrin (gammaCD) microparticles in a low-viscosity aqueous eye drop suspension. The mean (+/-standard deviation) diameter of the particles was 20.4+/-10.3 microm, with no particles larger than 60 microm. The aqueous suspension formulation was tested in rabbits and compared with an aqueous dexamethasone eye drop solution containing randomly methylated beta-cyclodextrin (RMbetaCD). The dexamethasone concentration was identical in both formulations (15 mg mL(-1)). The drug was administered to the left eye but determined in both eyes. The amount reaching different eye tissues via the topical route was determined by subtracting the amount found in the right eye from the amount found in the left eye. Two hours after single application of the dexamethasone/gammaCD eye drops to rabbits the mean (+/-s.d.) concentration in vitreous was 29+/-16 ng g(-1), 86% of which reached vitreous via the topical route and in retina the concentration was 57+/-22 ng g(-1) (49% via topical route). For the RMbetaCD the values were 22.6+/-9 and 66+/-49 ng g(-1) (73 and 14% via topical route), respectively. These steroid levels are comparable with the dexamethasone concentration achieved 1 month after intravitreal injection. The aqueous dexamethasone/gammaCD eye drop formulation was chemically stable during 7 months storage and well tolerated with no visible short-term side effects.

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] Using topical application to deliver therapeutic concentrations of drugs to the posterior segment of the eye remains very challenging. As a result, posterior segment diseases are usually treated by intravitreal injection or implant. While topical treatments are commonly used for anterior segment conditions, they sometimes require frequent applications. Eye drop formulations based on γ-cyclodextrin (γCD)-based nanoparticle aggregates were developed, which in animal models and clinical studies deliver therapeutic concentrations of drugs (dorzolamide and dexamethasone) to both anterior and posterior segments of the eye. An early study in humans showed dorzolamide/γCD eye drops could achieve comparable intraocular pressure decreases to commercial dorzolamide eye drops, but with less frequent application. Pilot studies with dexamethasone/γCD eye drops suggested that they could be effective in a range of conditions, including diabetic macular oedema, cystoid macular oedema and vitritis secondary to uveitis, postcataract surgery inflammation and postoperative treatment in trabeculectomy. Phase II studies with similar dexamethasone/γCD nanoparticle eye drops in diabetic macular oedema and postcataract surgery inflammation have recently been completed. This technology has the potential to be used with other classes of drug molecules and to replace or complement invasive treatments, providing safer, non-invasive therapies, particularly for posterior segment conditions, that can be self-administered as eye drops by patients.