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NCT06172257CompletedPhase 3

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
401 (actual)
First submitted
7 Dec 2023
Start date
15 Mar 2024
Primary completion date
2 Apr 2026
Lead sponsor
Oculis
NCT number
NCT06172257

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 401
  • From 15 Mar 2024 to the primary completion date, 2 Apr 2026
  • 62 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Other

  • Have macular edema considered to be because of a cause other than DME.
  • Have a decrease in BCVA because of causes other than DME.

Who the study is looking for

  • 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 prior to screening (Visit 1).

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
OFTALMOS, Instituto Oftalmologico de Alta Complejidad
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Buenos AiresArgentinaUnknown status
Fundacion Zambrano
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Buenos AiresArgentinaUnknown status
Buenos Aires Macula (BAM) Clinical Research
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CABAArgentinaUnknown status
Centro Privado de Ojos
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CABAArgentinaUnknown status
Organizacion Medica de Investigacion
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CABAArgentinaUnknown status
Centro De Ojos Loria Srl
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CABAArgentinaUnknown status
Charles Centro Oftalmológico
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Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Centro Privado de Ojos Romagosa
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CórdobaArgentinaUnknown status
Instituto de Microcirugía Ocular Córdoba (IMOC)
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CórdobaArgentinaUnknown status
Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital
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MendozaArgentinaUnknown status
Grupo Láser Visión
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RosarioArgentinaUnknown status
Oftalmologia Global
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RosarioArgentinaUnknown status
Centro de la Vision Dr. Kolton
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SaltaArgentinaUnknown status
Rising Retina Clinic
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AhmedabadIndiaUnknown status
Narayana Nethralaya
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BangaloreIndiaUnknown status
Lotus Eye Hospital and Institute
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CoimbatoreIndiaUnknown status
St. Theresa's Hospital
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HyderabadIndiaUnknown status
Agrawal Hospital
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JaipurIndiaUnknown status
GSVM Medical College
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KanpurIndiaUnknown status
Emanuelli Research & Development Center
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AreciboPuerto RicoUnknown status
California Retina Consultants
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BakersfieldUnited StatesUnknown status
Retina Consultants of Texas
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BellaireUnited StatesUnknown status
Ophthalmic Consultants of Boston
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BostonUnited StatesUnknown status
Sibia Eye Institute
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Boynton BeachUnited StatesUnknown status
Star Retina
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BurlesonUnited StatesUnknown status
Blue Ocean Clinical Research
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ClearwaterUnited StatesUnknown status
Advanced Research
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Coral SpringsUnited StatesUnknown status
Retina Specialists of Colorado
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DenverUnited StatesUnknown status
Erie Retina Research
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ErieUnited StatesUnknown status
Retina Group of Florida
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Fort LauderdaleUnited StatesUnknown status
Charles Retina Institute
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GermantownUnited StatesUnknown status
Associated Retina Consultants
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GilbertUnited StatesUnknown status
Mid Atlantic Retina Specialists
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HagerstownUnited StatesUnknown status
Cumberland Valley Retina Consultants
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HagerstownUnited StatesUnknown status
VitreoRetinal Consultants of NY
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HauppaugeUnited StatesUnknown status
Houston Eye Associates, North Loop
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HoustonUnited StatesUnknown status
Retina Associates of Southern California
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Huntington BeachUnited StatesUnknown status
Mississippi Retina Associates
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JacksonUnited StatesUnknown status
East Coast Institute for Research
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JacksonvilleUnited StatesUnknown status
Eye Care Center of Northern Colorado
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LongmontUnited StatesUnknown status
Piedmont Eye Center
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LynchburgUnited StatesUnknown status
Marietta Eye Clinic
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MariettaUnited StatesUnknown status
Retina Consultants of Southwest Florida
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NaplesUnited StatesUnknown status
Tennessee Retina
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NashvilleUnited StatesUnknown status
Illinois Retina Associates
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Oak ParkUnited StatesUnknown status
Stanford Byers Eye Institute
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Palo AltoUnited StatesUnknown status
Georgia Retina
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Peachtree CityUnited StatesUnknown status
Vision Research Solutions in Philadelphia
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PhiladelphiaUnited StatesUnknown status
Retinal Consultants of Arizona - Phoenix North
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PhoenixUnited StatesUnknown status
Associated Retina Consultants
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PhoenixUnited StatesUnknown status
Sierra Eye Associates
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RenoUnited StatesUnknown status
Austin Retina Associates
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Round RockUnited StatesUnknown status
Retinal Consultants Medical Group, Inc.
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SacramentoUnited StatesUnknown status
Retinal Consultants Medical Group
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SacramentoUnited StatesUnknown status
San Antonio Eye Center - Downtown Clinic
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San AntonioUnited StatesUnknown status
Medical Center Ophthalmology Associates
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San AntonioUnited StatesUnknown status
California Retina Consultants
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Santa BarbaraUnited StatesUnknown status
Island Retina
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ShirleyUnited StatesUnknown status
Macula Retina Vitreous Center
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TorranceUnited StatesUnknown status
Tyler Retina Consultants
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TylerUnited StatesUnknown status
Vitreoretinal Consultants of NY
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WestburyUnited StatesUnknown status
Palmetto Retina Center
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West ColumbiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.