OCS-01 Eye Drops for Macular Edema

Recruiting at 1 trial location

Overseen By Oculis Study Leader

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Oculis

Disqualifiers: Macular ischemia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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: Unknown

Duration: 52 weeks

350 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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. ^{2 3 5 9 10}

Research Team

Diana Do, MD

Principal Investigator

Stanford Byers Eye Institute

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.

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

Treatment Details

Interventions

• Dexamethasone ophthalmic suspension (OCS-01)

Trial Overview 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.

Participant Groups

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

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

Findings from Research

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]

In a study of 15 patients with non-infectious posterior segment uveitis, the dexamethasone intravitreal implant (Ozurdex) significantly reduced central retinal thickness (CRT) and improved best-corrected visual acuity (BCVA) after the first treatment, with 91.4% of eyes showing CRT reduction and 80% showing BCVA improvement.

The effectiveness of the DEX implant was maintained with repeat use, showing similar improvements in CRT and VA, indicating it can be a valuable adjunct treatment alongside other therapies for managing macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal Dexamethasone Implant for the Treatment of Macular Edema in Chronic Non-infectious Uveitis. Tsang, AC., Virgili, G., Abtahi, M., et al.[2018]

In a phase 4 study involving 177 patients with diabetic macular edema (DME), the dexamethasone intravitreal implant (DEX) significantly improved visual acuity, with an average increase of +9.1 letters after the first three injections.

The treatment also led to a substantial reduction in central retinal thickness (CRT) by an average of -137.7 μm, demonstrating its effectiveness in both visual and anatomical outcomes without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study. Singer, MA., Dugel, PU., Fine, HF., et al.[2022]

In real-life clinical practice, the average number of dexamethasone implant injections for diabetic macular edema (DME) is about 2.4 per year, with an average interval of approximately 4.9 months between treatments, based on data from three studies involving over 700 prescriptions and patient follow-ups.

The consistency in injection frequency across different studies suggests a need for further research to determine the optimal dosing regimen for dexamethasone in treating DME, as current practices may vary.

NCBI (Pubmed)

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. Querques, G., Darvizeh, F., Querques, L., et al.[2018]

In a study involving 1048 patients with diabetic macular edema, both the 0.7 mg and 0.35 mg dexamethasone intravitreal implants significantly improved best-corrected visual acuity (BCVA) compared to a sham treatment, with 22.2% and 18.4% of patients achieving a ≥15-letter improvement, respectively.

The safety profile of the DEX implants was acceptable, with manageable increases in intraocular pressure and a higher incidence of cataract-related adverse events in treated patients, but only a small percentage required surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Boyer, DS., Yoon, YH., Belfort, R., et al.[2022]

Dexamethasone implant (Ozurdex™) is generally considered a safe treatment with minimal adverse events, highlighting its favorable safety profile.

The study presents a rare case of a fractured Ozurdex™ implant occurring immediately after injection, providing insights into potential complications and their outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. Aljohani, SM., Al-Shehri, AM., Al-Rubaie, KR.[2021]

A retrospective case series reported on various surgical techniques used to address ocular complications following dexamethasone (DEX) implant injections, highlighting the need for individualized approaches.

Successful management of complications, including implant migration and acute endophthalmitis, emphasizes the importance of early surgical intervention to preserve eye anatomy and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management of Complications after Dexamethasone Implant. Sborgia, G., Niro, A., D'Oria, F., et al.[2022]

This study is the first to report that the absolute bioavailability of dexamethasone from topical suspensions is less than 2%, indicating limited effectiveness in reaching the aqueous humor after application.

Intracameral administration of dexamethasone showed a clearance rate of 13.6 µL/min and a volume of distribution of 990 µL, providing valuable pharmacokinetic parameters that can help in designing better ocular delivery systems for dexamethasone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical pharmacokinetics of dexamethasone suspensions in the rabbit eye: Bioavailability comparison. Naageshwaran, V., Ranta, VP., Toropainen, E., et al.[2022]

Dexamethasone, particularly in the form of the intravitreal implant (DEX implant), has been recognized as an effective treatment for diabetic macular oedema (DMO), which is a major cause of vision loss in working-age individuals.

The DEX implant has been approved by the FDA and EU for treating macular oedema related to retinal vein occlusion and non-infectious uveitis, highlighting its safety and efficacy in managing these eye conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema. Dutra Medeiros, M., Alkabes, M., Nucci, P.[2020]

The dexamethasone intravitreal implant (Ozurdex) effectively prevents the recurrence or worsening of cystoid macular edema (CME) in patients with noninfectious uveitis undergoing cataract surgery, as shown in a study of 17 eyes from 14 patients.

In particular, patients who received the DEX implant within 4 weeks before surgery experienced a significant reduction in central macular thickness (CMT), with an average decrease of 47.0 μm, compared to an increase in CMT for those who received the implant more than 4 weeks prior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Intravitreal Implant in the Treatment of Uveitic Macular Edema in the Perioperative Cataract Setting: A Case Series. Larochelle, MB., Smith, J., Dacey, MS.[2017]

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]

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

Intravitreal Dexamethasone Implant for the Treatment of Macular Edema in Chronic Non-infectious Uveitis. [2018]

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]

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]

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]

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

Fractured dexamethasone implant (OZURDEX®) following intravitreal injection. [2021]

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

Surgical Management of Complications after Dexamethasone Implant. [2022]

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

Topical pharmacokinetics of dexamethasone suspensions in the rabbit eye: Bioavailability comparison. [2022]

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

Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema. [2020]

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]