Clinical trial NCT05066997: A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
Official title: A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Keywords: Topical ophthalmic suspension
Eye drop
Lead sponsor: Oculis
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema

Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.

Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.

Eligibility criteria: Inclusion Criteria (selection) - Stage 1:

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 central subfield thickness (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 at Visit 1 (Screening).

Inclusion Criteria (selection) - Stage 2:

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 central subfield thickness (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 Visit 1 (Screening).

Exclusion criteria (selection) - Stage 1 and Stage 2:

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.

Primary outcomes:
measure: Mean Change in BCVA (Best Corrected Visual Acuity)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants with a 3-line or Greater Gain in BCVA
timeFrame: Baseline, Week 52
measure: Mean Change in BCVA
timeFrame: Baseline, Week 12 and Week 24
measure: Mean Change in Central Subfield Thickness (CST)
timeFrame: Baseline, Week 52
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse events (TEAEs)
timeFrame: Up to Week 52
Locations:
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Retina Associates
state: Arizona
city: Springdale
country: United States
facility: Retina Partners of Northwest Arkansas
state: Arkansas
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Modesto
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group
state: California
city: Redlands
country: United States
facility: California Eye Specialists Medical Group
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Santa Maria
country: United States
facility: California Retina Consultants
state: California
city: Torrance
country: United States
facility: Beverly Hills Institute of Ophthalmology
state: California
city: Waterford
country: United States
facility: Retina Group Of New England
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Jacksonville
country: United States
facility: Florida Retina Institute
state: Florida
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Elmhurst
country: United States
facility: Retina Associates
state: Illinois
city: Lemont
country: United States
facility: University Retina
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: St. Louis Park
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central New York
state: New York
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity (Meridian) Clinical Research
state: Ohio
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Philadelphia
country: United States
facility: Vision Research Solutions in Philadelphia
state: Pennsylvania
city: Beaufort
country: United States
facility: Retina Consultants of Charleston
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Retina Consultants of Austin/Austin Research Center for Retina
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Grapevine
country: United States
facility: Retina Center of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute PA d.b.a. Gulf Coast Eye Institute
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Retina Consultants
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Hong Kong
country: Hong Kong
facility: HKU Eye Centre
city: Kowloon
country: Hong Kong
facility: Chinese University of Hong Kong Eye Centre
city: Surat
country: India
facility: Shivam Retina Clinic and Eye Hospital
state: Gujarat
city: Bengaluru
country: India
facility: Nethra Eye Hospital
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences & Research Centre
state: Kerala
city: Nagpur
country: India
facility: Sarakshi Netralaya
state: Maharashtra
city: Bhubaneswar
country: India
facility: L V Prasad Eye Institute
state: Orissa
city: Noida
country: India
facility: ICARE Eye Hospital & Post Graduate Institute
state: Uttar Pradesh
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Taichung
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: University Retina - Lemont
name: Veeral S Sheth, MD
role: PRINCIPAL_INVESTIGATOR
References: