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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05066997
• Other study ID #: DX219
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 19, 2021
• Est. completion date: August 30, 2025

Study information

• Verified date: January 2023
• Source: Oculis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 497
• Est. completion date: August 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria (selection) :

1. Have a signed informed consent form before any study-specific procedures are performed.

2. 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).

3. 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):

1. Have macular edema considered to be because of a cause other than DME.

2. 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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Active treatment arm: OCS-01 (dexamethasone)
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
• Vehicle
The vehicle drug (placebo) eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit

Locations

Country	Name	City	State
United States	Oculis Investigative Site	Beverly Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Oculis	Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 52
Secondary	Safety measures	• Incidence in Treatment Emergent Adverse Events assessed by site	at each visit throughout the study up to week 52