History of Changes for Study: NCT06172257

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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	A	B	Submitted Date	Changes
1			December 7, 2023	None (earliest Version on record)
2			March 5, 2024	Recruitment Status, Study Status, Contacts/Locations and Oversight

Comparison Format:

Study NCT06172257
Submitted Date: December 7, 2023 (v1)

Study Identification


Unique Protocol ID:	DX221
Brief Title:	Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)
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
Secondary IDs:

Study Status


Record Verification:	December 2023
Overall Status:	Not yet recruiting
Study Start:	December 2023
Primary Completion:	December 2025 [Anticipated]
Study Completion:	December 2025 [Anticipated]

First Submitted:	December 7, 2023
First Submitted that Met QC Criteria:	December 7, 2023
First Posted:	December 15, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	December 7, 2023
Last Update Posted:	December 15, 2023 [Actual]

Sponsor/Collaborators

Study Description


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 Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	350 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 Names: 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 Names: Placebo

Outcome Measures


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


Minimum Age:	18 Years
Maximum Age:	85 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria (selection): Have a signed informed consent form before any study-specific procedures are performed. 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). 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): Have macular edema considered to be because of a cause other than DME. Have a decrease in BCVA because of causes other than DME. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Contacts/Locations


Central Contact Person:	Oculis Study Leader Telephone: +41 21 711 3970 Email: info@oculis.ocm
Study Officials:	Arshad Khanani, MD Principal Investigator Sierra Eye Associates
Locations:	United States, Nevada
	Oculis Investigative Site - Sierra Eye Associates Reno, Nevada, United States, 89502