OCS-01 for Macular Edema

(LEOPARD Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Quan Dong Nguyen

Must be taking: Topical NSAID, Topical corticosteroids

Must not be taking: Immunosuppressives, Biologics

Disqualifiers: Diabetes, Glaucoma, Active infection, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01. Macular edema is a condition in which there is collection of fluid (edema) in the back of the eye (Macula) and it can lead to severe loss of vision. Among other causes, macular edema can happen because of a disease of the eye called Uveitis, and also after eye surgery. Treatment of macular edema remains a challenge as the condition may persist for several months and may lead to irreversible changes in the eye and poor vision. In the LEOPARD study the investigators wish to see how safe is the study drug (OCS-01) and how well it works, in resolving the fluid collection in the eye in patients with Uveitis or in patients who have had eye surgery. Participants will undergo detailed eye exam, and record their eye and medical history to see what their disease status is and if they can be included in the study based on the study criteria. If included, they will take the study drug OCS-01 in different doses for 24 weeks. During the study period, they will have regular eye exams to ensure their safety and to assess the usefulness of the study drug.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop all current medications. However, you cannot use other ophthalmic formulations during the study, except for intraocular pressure-lowering eye drops if needed. Also, if you have UME, your dose of immunosuppressives must be stable for 2 months before the trial, and oral prednisone must be stable for 1 month before the trial. Please consult with the trial team for specific guidance on your medications.

What data supports the idea that OCS-01 for Macular Edema is an effective treatment?

The available research shows that OCS-01, a topical dexamethasone ophthalmic suspension, is being evaluated for its effectiveness in treating diabetic macular edema. However, the research does not provide specific data or outcomes for OCS-01's effectiveness. In comparison, other treatments like the sustained-release dexamethasone implant (Ozurdex) have shown promise in treating macular edema from various causes, including diabetic retinopathy and retinal vein occlusion, by providing controlled drug release and potentially fewer side effects. This suggests that while OCS-01 is under investigation, other dexamethasone-based treatments have demonstrated effectiveness in clinical settings.

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What safety data is available for OCS-01 treatment?

The safety data for OCS-01, a novel topical dexamethasone formulation, has been evaluated in studies for inflammation and pain post-cataract surgery and diabetic macular edema. The study titled 'OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery' compared OCS-01 with a vehicle for safety and efficacy. Another study, 'Topical treatment of diabetic macular edema using dexamethasone ophthalmic suspension,' evaluated OCS-01 in diabetic macular edema. These studies provide insights into the safety profile of OCS-01 in different ophthalmic conditions.

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Is the drug OCS-01 a promising treatment for macular edema?

Yes, OCS-01 is a promising treatment for macular edema. It is a new form of the drug dexamethasone, which is used to reduce swelling in the eye. This drug can be applied as eye drops, making it easier to use compared to other treatments that require injections. This could help people with macular edema, a condition that can cause vision loss, by providing a more convenient and effective way to manage their condition.

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Eligibility Criteria

Adults over 18 with Uveitic macular edema (UME) or post-surgical macular edema (PSME), who have had the condition for less than 3 years (UME) or less than 1 year (PSME). Participants must have a certain level of vision impairment and be able to attend all study visits. Those with macular edema due to other causes, significant eye diseases, high myopia, history of steroid-induced increased eye pressure, active infections, pregnancy/breastfeeding, unstable uveitis or immunosuppressive treatment are excluded.

Inclusion Criteria

I tried a skin cream for pain or swelling without success for 1 to 3 months.

An ETDRS BCVA letter score ≤ 70 (Snellen 20/40) and ≥ 35 (Snellen 20/200) in the study eye at baseline (Visit 2)

I am 18 years old or older.

Exclusion Criteria

Pregnancy/Breastfeeding

My dose of immunosuppressants has not increased in the last 2 months.

I can use eye drops for high eye pressure if needed during the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Loading

Participants receive 01 drop of OCS-01, six times a day from baseline until week 4

4 weeks

Regular visits for eye exams

Treatment

Participants continue their assigned treatments until week 12, with primary endpoint assessments at week 12

8 weeks

Regular visits for eye exams

Follow-up

Participants receive treatment based on retreatment criteria from week 12 to week 24

12 weeks

Regular visits for eye exams

Participant Groups

The LEOPARD trial is testing OCS-01 steroid eye drops' safety and effectiveness in treating fluid buildup in the back of the eye caused by UVE or following surgery. Patients will use different doses for 24 weeks while undergoing regular detailed eye exams to monitor their response and any side effects.

Group I: Low dose PSME - 3 drops of OCS-01 and 3 drops of Placebo Experimental Treatment 1 Intervention

From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, the participants randomized to low dose group will receive 01 drop of OCS-01 three times a day and 01 drop of placebo three times a day, (total 6 drops each day) until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.

Group II: Low Dose UME 3 drops OCS-01 and 3 drops Placebo Experimental Treatment 1 Intervention

From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, the participants randomized to low dose group will receive 01 drop of OCS-01 three times a day and 01 drop of placebo three times a day,( total 6 drops each day) until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.

Group III: High dose PSME - 6 drops of OCS-01 Experimental Treatment 1 Intervention

From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, participants randomized to the high dose group will continue to receive 01 drop of OCS-01 six times a day until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.

Group IV: High Dose UME - 6 drops OCS-01 Experimental Treatment 1 Intervention

From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day. At week 4, participants randomized to the high dose group will continue to receive 01 drop of OCS-01 six times a day until the primary end point at week 12. Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Retina Associates of Southern California Huntington Beach, CA

Massachusetts Eye Research and Surgery Institution Boston, MA

Erie Retina Research Erie, PA

Retina Vitreous Associates Medical Group Beverly Hills, CA

More Trial Locations

Who Is Running the Clinical Trial?

Quan Dong Nguyen Lead Sponsor

Oculis Industry Sponsor

Global Ophthalmic Research Center (GORC) Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Repeated treatment for macular edema in vein occlusion by intravitreal implant of dexamethasone. [2021] Macular edema (ME) treatment has benefited from the recent intravitreal pharmacotherapy development of an intravitreal implant of dexamethasone (Ozurdex(®), Allergan, Irvine, Calif., USA). However, its efficiency has never been illustrated beyond 3 injections.

2. 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).

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical applications of the sustained-release dexamethasone implant for treatment of macular edema. [2021] Macular edema is one of the leading causes of vision loss among patients with retinal vein occlusion, diabetic retinopathy, and posterior chamber inflammatory disease. However, the treatment of macular edema is considerably limited by the difficulty in delivering effective doses of therapeutic agents into the vitreous cavity. In recent years, the development of a sustained-release dexamethasone intravitreal implant (Ozurdex(®)) has enabled more controlled drug release at a stable rate over a long period of time, with a potentially lower rate of adverse events. Clinical studies indicate that this dexamethasone implant is a promising new treatment option for patients with persistent macular edema resulting from retinal vein occlusion, diabetic retinopathy, and uveitis or Irvine-Gass syndrome.

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

Treatment of macular edema associated with retinal vein occlusion using sustained-release dexamethasone implants in a clinical setting. [2017] To evaluate the clinical effect, safety, and administration procedure of slow-release dexamethasone implants (Ozurdex®) for macular edema secondary to retinal vein occlusion in clinical praxis.

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

Safety and efficacy of a dexamethasone anterior segment drug delivery system in patients after phacoemulsification. [2013] To compare the safety and efficacy of the Surodex dexamethasone anterior segment drug delivery system (Oculex Pharmaceuticals, Inc.) and dexamethasone 0.1% eyedrops (Maxidex) in patients with inflammation after cataract surgery.

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

OCS-01 (Novel Topical Dexamethasone Formulation) in Inflammation and Pain Post Cataract Surgery: A Randomized, Double-Masked, Vehicle-Controlled Study. [2022] The goal of this study was to compare topical dexamethasone 1.5% in a novel formulation (OCS-01) once daily and BID versus vehicle for the treatment of inflammation and pain after cataract surgery.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema. [2022] To evaluate the efficacy and safety of intravitreal implant of dexamethasone (Ozurdex®) in diabetic macular edema (DME).

8. 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).