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Corticosteroid

Dexamethasone Eye Drops for Diabetic Macular Edema

Phase 2 & 3

Waitlist Available

Led By Suk Jin Moon, 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 a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Study Summary

This trial is testing a new eye drop for people with diabetic macular edema. The goal is to see if it is effective and safe.

Who is the study for?

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.Check my eligibility

What is being tested?

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.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 in the eye due to its steroid component.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have diabetes with an HbA1c level of 12.0% or lower.

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 in BCVA (Best Corrected Visual Acuity) ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity

Secondary outcome measures

Safety measures

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatment arm: OCS-01Experimental Treatment1 Intervention

In Stage 1: Active treatment arm: OCS-01 - dosing regimen 1 for 6 weeks followed by dosing regimen 2 for 6 weeks. In Stage 2, subjects will receive the dosing regimen determined from Stage 1 for OCS-01 for 52 weeks.

Group II: Vehicle placebo armPlacebo Group1 Intervention

In stage 1: Vehicle: dosing regimen 1 for 6 weeks followed by dosing regimen 2 for 6 weeks. In Stage 2, subjects will receive the matched dosing regimen for Vehicle for 52 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Syneos HealthOTHER

172 Previous Clinical Trials

67,957 Total Patients Enrolled

OculisLead Sponsor

8 Previous Clinical Trials

1,233 Total Patients Enrolled

David S. Boyer, MDStudy ChairRetina-Vitreous Associates Medical Group

1 Previous Clinical Trials

65 Total Patients Enrolled

Media Library

OCS-01 (dexamethasone) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05066997 — Phase 2 & 3

Diabetic Macular Edema Research Study Groups: Active treatment arm: OCS-01, Vehicle placebo arm

Diabetic Macular Edema Clinical Trial 2023: OCS-01 (dexamethasone) Highlights & Side Effects. Trial Name: NCT05066997 — Phase 2 & 3

OCS-01 (dexamethasone) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05066997 — Phase 2 & 3

Frequently Asked Questions

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

If a potential patient is not yet 60 years old, can they still enroll in this clinical trial?

"For this particular study, the researchers are only recruiting patients that fall between 18-75 years old. However, there are 85 other clinical trials currently underway that are looking for test subjects that are under 18 and 608 trials for patients over the age of 65."

Answered by AI

What is the primary ailment that OCS-01 (dexamethasone) is used to treat?

"The active treatment arm of this study, OCS-01 (dexamethasone), can be used to treat ophthalmia, sympathetic, eye, and branch retinal vein occlusion."

Answered by AI

Is it still possible to join this research project?

"Yes, this is an active trial that was originally posted on October 19th, 2021 and updated on November 19th, 2021 according to the clinicaltrials.gov website."

Answered by AI

For which types of patients is this trial designed?

"482 participants are being recruited for this study that is testing a new medication for diabetic macular edema. To qualify, patients must be between 18-75 years old and have a medical diagnosis of dme."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema

2021. "Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05066997.

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