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

Diabetic Macular Edema Clinical Trial

Official title:

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172257
• Other study ID #: DX221
• Status: Recruiting
• Phase: Phase 3
• Start date: December 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Oculis
• Contact: Oculis Study Leader
• Phone: +41 21 711 3970
• Email: info[@]oculis.ocm
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).

Description:

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2025
• Est. primary completion date: December 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 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 an HbA1c of = 10.0% prior to screening (Visit 1).

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.

3. 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:
• Dexamethasone ophthalmic suspension (OCS-01)
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. Subjects will be dosed with eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
• 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. Subjects will be dosed with eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

Locations

Country	Name	City	State
United States	Oculis Investigative Site - Sierra Eye Associates	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Oculis	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in BCVA (Best Corrected Visual Acuity)	Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity	Week 52