A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

Oculis

Status and phase: Active, not recruiting; Phase 3

Conditions: Diabetic Macular Edema

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06172257

DX221

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 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema

Enrollment: 401 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

401 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 ophthalmic suspension

Placebo Comparator group

Description:

Vehicle of OCS-01

Treatment:

Drug: Vehicle