OCS-01 Eye Drops for Macular Edema

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Diana Do, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Oculis

Disqualifiers: Macular ischemia, others

Pivotal Trial (Near Approval)

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 Eye Drops for Macular Edema?

Research shows that dexamethasone, a key ingredient in OCS-01, is effective in treating diabetic macular edema (DME) when used as an intravitreal implant (a tiny device placed inside the eye). This suggests that the dexamethasone in OCS-01 eye drops may also help reduce swelling in the eye for people with macular edema.

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Is OCS-01 Eye Drops safe for use in humans?

Dexamethasone, used in OCS-01 eye drops, is generally considered safe with few adverse events reported, although rare complications can occur, such as with the Ozurdex implant version.

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How is the drug OCS-01 different from other treatments for macular edema?

OCS-01 is a dexamethasone eye drop formulation, which is unique because it offers a non-invasive alternative to the commonly used dexamethasone intravitreal implant (Ozurdex) that requires injection into the eye. This eye drop form could potentially provide a more convenient and less invasive option for patients with macular edema.

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Eligibility Criteria

This trial is for individuals with Diabetic Macular Edema (DME), a condition where blood vessels leak into the retina causing swelling. Participants should have this specific eye condition to qualify.

Inclusion Criteria

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

I have diabetes with an HbA1c of 10% or less.

My eye condition involves fluid buildup and a central retinal thickness of 310 µm or more.

Exclusion Criteria

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

My vision loss is not due to diabetic macular edema.

My macular edema is not due to diabetic macular edema.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OCS 01 Eye Drops or Vehicle for the treatment of Diabetic Macular Edema

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study is testing OCS-01, a dexamethasone ophthalmic suspension, against a placebo (Vehicle) to see if it's more effective and safe in treating DME when applied as eye drops.

Group I: OCS-01 Experimental Treatment 1 Intervention

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

Group II: Vehicle ophthalmic suspension Placebo Group 1 Intervention

Vehicle of OCS-01

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

🇺🇸 Approved in United States as Dexamethasone ophthalmic suspension for:

• Diabetic Macular Edema
• Uveitis
• Macular Edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
• Non-infectious uveitis affecting the posterior segment of the eye
• Conjunctivitis
• Allergic conjunctivitis
• Iritis
• Cyclitis
• Keratitis
• Postoperative ocular inflammation

🇪🇺 Approved in European Union as Dexamethasone ophthalmic suspension for:

• Diabetic Macular Edema
• Uveitis
• Macular Edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
• Non-infectious uveitis affecting the posterior segment of the eye
• Conjunctivitis
• Allergic conjunctivitis
• Iritis
• Cyclitis
• Keratitis
• Postoperative ocular inflammation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Oculis Investigative Site - Sierra Eye Associates Reno, NV

Oculis Investigative Site - Stanford Byers Eye Institute Palo Alto, CA

Who Is Running the Clinical Trial?

Oculis Lead Sponsor

ICON plc Industry Sponsor

References

1. 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).

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

Intravitreal Dexamethasone Implant for the Treatment of Macular Edema in Chronic Non-infectious Uveitis. [2018] To report observations on the single and repeat use of the dexamethasone (DEX) intravitreal implant (Ozurdex; Allergan, Inc, Irvine, CA) for the treatment of macular edema in patients with non-infectious posterior segment uveitis.

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

Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study. [2022] Dexamethasone intravitreal implant (DEX) (Ozurdex; Allergan plc, Dublin, Ireland) is approved for the treatment of diabetic macular edema (DME). This study assessed the real-world effectiveness, safety, and reinjection interval of DEX in adult patients with DME.

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

Assessment of the Real-Life Usage of Intravitreal Dexamethasone Implant in the Treatment of Chronic Diabetic Macular Edema in France. [2018] Intravitreal steroids, including dexamethasone implant (Ozurdex(®)), are effective for the treatment of diabetic macular edema (DME). However, the dosing regimen for Ozurdex in DME is unclear, and thus, this study was designed to evaluate the dosing regimen for dexamethasone in real-life clinical practice.

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

Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. [2022] To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).

6. India pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. [2021] Dexamethasone implant (Ozurdex™) is a relatively safe medication with few adverse events can happen. We demonstrate clinical course and images of a rare case of fractured intravitreal Ozurdex™ implant that observed immediately following injection and its final outcome.

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

Surgical Management of Complications after Dexamethasone Implant. [2022] To report surgical management of ocular complications occurred after dexamethasone (DEX) implant (Ozurdex®) injection.

8. Netherlands pubmed.ncbi.nlm.nih.gov

Topical pharmacokinetics of dexamethasone suspensions in the rabbit eye: Bioavailability comparison. [2022] Topical corticosteroids are used to treat inflammation of the anterior segment. Due to their low water-solubility, they are often formulated as suspensions, but ocular bioavailability of the suspensions is not known. Herein, ocular pharmacokinetics of dexamethasone in albino rabbits was investigated following intracameral administration of dexamethasone solution and topical administration of three commercial suspensions: Maxidex®, TobraDex®, and TobraDexST®. Dexamethasone concentrations in tear fluid, cornea, aqueous humor, conjunctiva and iris-ciliary body were determined. Non-compartmental analysis was performed to estimate the pharmacokinetic parameters of dexamethasone. Following intracameral administration, the clearance and the apparent volume of distribution were estimated to be 13.6 µL/min and 990 µL, respectively. After topical administration, the absolute aqueous humor bioavailability for dexamethasone (

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema. [2020] Diabetic macular oedema (DMO) is a leading cause of vision loss in the working-age population worldwide. Corticosteroid drugs have been demonstrated to inhibit the expression of both the vascular endothelial growth factor (VEGF) gene and other anti-inflammatory mediators, such as prostaglandins. Triamcinolone, fluocinolone and dexamethasone are the main steroids that have been studied for the treatment of macular oedema. Over the last few years, several studies have suggested an important role for dexamethasone in the management of DMO. The dexamethasone intravitreal implant (DEX implant) (Ozurdex®; Allergan, Inc., Irvine, CA) is a novel approach approved by the US Food and Drug Administration (FDA) and by the EU for the intravitreal treatment of macular oedema after branch or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye. We reviewed manuscripts that had investigated the pharmacokinetics, efficacy and safety of the DEX implant regarding DMO treatment.

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

Dexamethasone Intravitreal Implant in the Treatment of Uveitic Macular Edema in the Perioperative Cataract Setting: A Case Series. [2017] To examine the efficacy of the dexamethasone (DEX) intravitreal implant (Ozurdex; Allergan, Inc, Irvine, California, USA) in the control of uveitic macular edema in the perioperative setting of cataract surgery.