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

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema. - (DIAMOND-2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071429

Enrollment

350

Registered

2024-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications

Interventions

Intervention1: 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 n

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 acuityTimepoint: Week 52	—

Secondary

Measure	Time frame
Proportion of subjects with 3-line or greater gain in BCVA ETDRS letters compared with baselineTimepoint: Week 52	—

Countries

Argentina, Bulgaria, Canada, Czech Republic, France, Germany, India, Italy, Republic of Korea, Spain, United States of America

Contacts

Public ContactDr Aparna Parikh

Pharmaceutical Research Associates India Private Limited

Aparna.Parikh@iconplc.com914497032707

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026