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

Primary Purpose

Diabetic Macular Edema

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Active treatment arm: OCS-01 (dexamethasone)

Vehicle

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (selection) :

Have a signed informed consent form before any study-specific procedures are performed.
Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
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).

Exclusion criteria (selection):

Have macular edema considered to be because of a cause other than DME.
Have a decrease in BCVA because of causes other than DME (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, nonretinal condition, substantial cataract, macular ischemia).

2) Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Sites / Locations

Oculis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment arm: OCS-01

Vehicle placebo arm

Arm Description

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.

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.

Outcomes

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

Stage 1: Mean change in BCVA ETDRS letters score at Visit 5 (Week 6) compared with baseline. Stage 2: Mean change in BCVA ETDRS letters score at Visit 9 (Week 52) compared with baseline.

Secondary Outcome Measures

Safety measures

• Incidence in Treatment Emergent Adverse Events assessed by site

Full Information

NCT ID

NCT05066997

First Posted

September 2, 2021

Last Updated

January 13, 2023

Sponsor

Oculis

Collaborators

Syneos Health

1. Study Identification

Unique Protocol Identification Number

NCT05066997

Brief Title

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

Official Title

A Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oculis

Collaborators

Syneos Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME

Detailed Description

This trial is a Phase 3 Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DME). Stage 1: To select a dosing regimen for OCS-01in subjects with DME Stage 2: To confirm the efficacy and safety of the selected dosing regimen of OCS01 in subjects with DME.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

497 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active treatment arm: OCS-01

Arm Type

Experimental

Arm Description

Arm Title

Vehicle placebo arm

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Active treatment arm: OCS-01 (dexamethasone)

Other Intervention Name(s)

Dexamethasone

Intervention Description

The interventional drug OCS-01 eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit

Intervention Type

Drug

Intervention Name(s)

Vehicle

Other Intervention Name(s)

Placebo

Intervention Description

The vehicle drug (placebo) eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit

Primary Outcome Measure Information:

Title

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

Description

Stage 1: Mean change in BCVA ETDRS letters score at Visit 5 (Week 6) compared with baseline. Stage 2: Mean change in BCVA ETDRS letters score at Visit 9 (Week 52) compared with baseline.

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Safety measures

Description

• Incidence in Treatment Emergent Adverse Events assessed by site

Time Frame

at each visit throughout the study up to week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (selection) : Have a signed informed consent form before any study-specific procedures are performed. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 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). Exclusion criteria (selection): Have macular edema considered to be because of a cause other than DME. Have a decrease in BCVA because of causes other than DME (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, nonretinal condition, substantial cataract, macular ischemia). 2) Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David S. Boyer, MD

Organizational Affiliation

Retina-Vitreous Associates Medical Group

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Arshad Khanani, MD

Organizational Affiliation

Sierra Eye Associates

Official's Role

Study Chair

Facility Information:

Facility Name

Oculis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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