Clinical trial NCT06172257: A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: Topical ophthalmic suspension
Eye drop
Lead sponsor: Oculis
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 401
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 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema

Eligibility 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 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.

Primary outcomes:
measure: Mean Change from Baseline 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: Gilbert
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona - Phoenix North
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Huntington Beach
country: United States
facility: Retina Associates of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford Byers Eye Institute
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Center
state: California
city: Denver
country: United States
facility: Retina Specialists of Colorado
state: Colorado
city: Longmont
country: United States
facility: Eye Care Center of Northern Colorado
state: Colorado
city: Boynton Beach
country: United States
facility: Sibia Eye Institute
state: Florida
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research
state: Florida
city: Coral Springs
country: United States
facility: Advanced Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Naples
country: United States
facility: Retina Consultants of Southwest Florida
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Peachtree City
country: United States
facility: Georgia Retina
state: Georgia
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Jackson
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Hauppauge
country: United States
facility: VitreoRetinal Consultants of NY
state: New York
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Westbury
country: United States
facility: Vitreoretinal Consultants of NY
state: New York
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Vision Research Solutions in Philadelphia
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Burleson
country: United States
facility: Star Retina
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates, North Loop
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center - Downtown Clinic
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Tyler
country: United States
facility: Tyler Retina Consultants
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Caba
country: Argentina
facility: Centro De Ojos Loria Srl
state: Buenos Aires
city: Caba
country: Argentina
facility: Centro Privado de Ojos
state: Buenos Aires
city: Caba
country: Argentina
facility: Organizacion Medica De Investigacion
state: Buenos Aires
city: Caba
country: Argentina
facility: Buenos Aires Macula (BAM) Clinical Research
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Charles Centro Oftalmológico
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Centro Privado de Ojos Romagosa
state: Córdoba
city: Rosario
country: Argentina
facility: Grupo Laser Vision
state: Santa Fe
city: Rosario
country: Argentina
facility: Oftalmologìa Global
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Fundacion Zambrano
city: Buenos Aires
country: Argentina
facility: Oftalmos - Instituto Oftalmológico de Alta Complejidad
city: Córdoba
country: Argentina
facility: Instituto de Microcirugía Ocular Córdoba (IMOC)
city: Mendoza
country: Argentina
facility: Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital
city: Salta
country: Argentina
facility: Centro de la Vision Dr. Kolton
city: Ahmedabad
country: India
facility: Rising Retina Clinic
state: Gujarat
city: Bangalore
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Jaipur
country: India
facility: Agrawal Hospital
state: Rajasthan
city: Coimbatore
country: India
facility: Lotus Eye Hospital and Institute
state: Tamil Nadu
city: Hyderabad
country: India
facility: St. Theresa's Hospital
state: Telangana
city: Kanpur
country: India
facility: GSVM Medical College
state: Uttar Pradesh
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center
Study officials:
affiliation: Stanford Byers Eye Institute
name: Diana Do, MD
role: PRINCIPAL_INVESTIGATOR
References: