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

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ClinicalTrials.gov Identifier: NCT06172257
Recruitment Status : Recruiting
First Posted : December 15, 2023
Last Update Posted : March 7, 2024
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Oculis

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Dexamethasone ophthalmic suspension (OCS-01) Drug: Vehicle Phase 3

Detailed 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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 15, 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: OCS-01
dexamethasone ophthalmic suspension,1.5% [15 mg/mL]
 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).

Other Name: Dexamethasone
Placebo Comparator: Vehicle ophthalmic suspension
Vehicle of OCS-01
 Drug: 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).

Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in BCVA (Best Corrected Visual Acuity) [ Time Frame: Week 52 ]
    Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06172257


Contacts
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Contact: Oculis Study Leader +41 21 711 3970 info@oculis.ocm

Locations
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United States, Nevada
Oculis Investigative Site - Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
Sponsors and Collaborators
Oculis
ICON plc
Investigators
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Principal Investigator: Arshad Khanani, MD Sierra Eye Associates
More Information
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Responsible Party: Oculis
ClinicalTrials.gov Identifier: NCT06172257    
Other Study ID Numbers: DX221
First Posted: December 15, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oculis:
Topical ophthalmic suspension
Eye drop
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action