← Back to Search

Corticosteroid

OCS-01 for Diabetic Macular Edema

Phase 3

Recruiting

Led By Arshad Khanani, MD

Research Sponsored by Oculis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1).

Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Study Summary

This trial looks at an eye treatment to help people with diabetes-related vision problems.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of OCS-01 may include increased pressure inside the eye, cataract formation, and possible risk of infections or allergic reactions from the eye drops.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change from baseline in BCVA (Best Corrected Visual Acuity)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OCS-01Experimental Treatment1 Intervention

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

Group II: Vehicle ophthalmic suspensionPlacebo Group1 Intervention

Vehicle of OCS-01

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OculisLead Sponsor

8 Previous Clinical Trials

1,380 Total Patients Enrolled

ICON plcIndustry Sponsor

80 Previous Clinical Trials

24,754 Total Patients Enrolled

Arshad Khanani, MDPrincipal InvestigatorSierra Eye Associates

5 Previous Clinical Trials

724 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research project?

"The information on clinicaltrials.gov suggests that this specific experimentation is no longer accepting candidates. First posted December 1st 2023, this trial was last amended seven days later and has since closed its doors to new participants; however, 120 other trials are still recruiting at present."

Answered by AI

To whom is enrollment for this trial open?

"In order to be admitted into this medical trial, patients must suffer from diabetic macular edema and fall between the ages of 18 - 85. A total of 350 individuals will be accepted."

Answered by AI

Does the enrolled population of this study extend to seniors?

"This trial is open to participants aged 18-85. Separately, there are 7 trials for minors and 109 studies that accept people older than 65 years old."

Answered by AI

Does the FDA sanction OCS-01 for public use?

"OCS-01 has been assigned a safety rating of 3 due to the multitude of trials that have demonstrated its efficacy and multiple levels of data indicating its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)

2023. "Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06172257.

All > Macular Edema