A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

Oculis

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Dexamethasone ophthalmic suspension (OCS-01); Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05066997

DX219

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS- 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).

Full description

A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema

Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.

Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.

Enrollment: 552 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (selection) - Stage 1:

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 at Visit 1 (Screening).

Inclusion Criteria (selection) - Stage 2:

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 prior to Visit 1 (Screening).

Exclusion criteria (selection) - Stage 1 and Stage 2:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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552 participants in 2 patient groups, including a placebo group

OCS-01

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone ophthalmic suspension (OCS-01)

Vehicle Vehicle

Placebo Comparator group

Description:

Placebo is a Vehicle ophthalmic suspension of OCS-01

Treatment:

Drug: Vehicle