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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

Tracking Information
First Submitted Date  ICMJE December 7, 2023
First Posted Date  ICMJE December 15, 2023
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE December 15, 2023
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2023)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)
Official Title  ICMJE A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: OCS-01
    dexamethasone ophthalmic suspension,1.5% [15 mg/mL]
    Intervention: Drug: Dexamethasone ophthalmic suspension (OCS-01)
  • Placebo Comparator: Vehicle ophthalmic suspension
    Vehicle of OCS-01
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2023)		 350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oculis Study Leader +41 21 711 3970 info@oculis.ocm
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06172257
Other Study ID Numbers  ICMJE DX221
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Oculis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Oculis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE ICON plc
Investigators  ICMJE
Principal Investigator: Arshad Khanani, MD Sierra Eye Associates
PRS Account Oculis
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP