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NCT06847854Active, not recruitingPhase 1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

A Phase I, Multipart, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7497372 Following Intravitreal Administration in Participants With Diabetic Macular Edema (Part 1 Non-Randomized, Open-Label, Multiple Ascending Dose; Part 2 Randomized, Double-Masked)

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
151 (actual)
First submitted
21 Feb 2025
Start date
8 Dec 2022
Primary completion date
16 Nov 2026
Lead sponsor
Genentech, Inc.
NCT number
NCT06847854

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 151
  • From 8 Dec 2022 to the primary completion date, 16 Nov 2026
  • 38 sites in 2 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.

Prior treatment

  • Any major illness or major surgical procedure ≤ 4 weeks before Day 1
  • Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
  • Active cancer ≤ 1 year prior to Day 1
  • Cerebral vascular accident (including stroke and transient ischemic attack) or myocardial infarction ≤ 24 weeks prior to Day 1
  • Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
  • Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
  • Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time

Other illness

  • History of vitreoretinal surgery/pars plana vitrectomy
  • History of any glaucoma surgery including laser glaucoma procedures
  • Any active intra- or periocular infection on Day 1
  • Any active or history of Intraocular inflammation

Lab values

  • HbA1c ≥ 12% at screening

Other

  • Uncontrolled glaucoma
  • Any proliferative DR

Who the study is looking for

  • Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world health organization (WHO) and/or American Diabetes Association
  • Participant consents to AH collection
  • Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\]) if deemed feasible and safe by the Investigator.
  • Macular thickening secondary to DME involving the center of the fovea with CST \>= 325 µm at screening
  • Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (both inclusive) at screening
  • Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
  • Diagnosis of non-proliferative DR
  • Treatment-naive and Pre-treated participants after washout

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

Full criteria on ClinicalTrials.gov

Sites (38)

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

SiteCityCountrySite status
Emanuelli Research and Development Center, LLC
Coordinator of this site? Confirm its status
AreciboPuerto RicoUnknown status
Austin Clinical Research, LLC
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AustinUnited StatesUnknown status
Ross Eye Institute
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BuffaloUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Erie Retinal Surgery
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ErieUnited StatesUnknown status
Verum Research, LLC
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EugeneUnited StatesUnknown status
Retina Group of Washington
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FairfaxUnited StatesUnknown status
Emerson Clinical Research Institute
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Falls ChurchUnited StatesUnknown status
Charles Retina Institute
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GermantownUnited StatesUnknown status
Global Research Management
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GlendaleUnited StatesUnknown status
Retina Associates of Michigan
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Grand BlancUnited StatesUnknown status
Foundation for Vision Research
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Grand RapidsUnited StatesUnknown status
Cumberland Valley Retina PC
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HagerstownUnited StatesUnknown status
Arkansas Retina Research
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Little RockUnited StatesUnknown status
Piedmont Eye Center
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LynchburgUnited StatesUnknown status
Mississippi Retina Associates
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MadisonUnited StatesUnknown status
Florida Eye Associates
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MelbourneUnited StatesUnknown status
Barnet Dulaney Perkins Eye Center
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MesaUnited StatesUnknown status
Retinal Consultants Medical Group
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ModestoUnited StatesUnknown status
Carolina Eyecare Physicians
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Mt. PleasantUnited StatesUnknown status
Retina Associates of NY
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New YorkUnited StatesUnknown status
Wagner Kapoor Institute
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NorfolkUnited StatesUnknown status
Retinal Consultants of AZ, Ltd
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PeoriaUnited StatesUnknown status
Mid Atlantic Retina
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PhiladelphiaUnited StatesUnknown status
Associated Retina Consultants
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PhoenixUnited StatesUnknown status
EyeHealth Northwest
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PortlandUnited StatesUnknown status
Sierra Eye Associates
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RenoUnited StatesUnknown status
Retina Consultants Minnesota
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Saint Louis ParkUnited StatesUnknown status
Brown Retina Institute
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SchertzUnited StatesUnknown status
MedEye Associates
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South MiamiUnited StatesUnknown status
Spokane Eye Clinic
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SpokaneUnited StatesUnknown status
The Retina Institute
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St LouisUnited StatesUnknown status
East Florida Eye Institute
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StuartUnited StatesUnknown status
Retina Consultants of Texas
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The WoodlandsUnited StatesUnknown status
Bay Area Retina Associates
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Walnut CreekUnited StatesUnknown status
Retina Specialists of Tampa
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Wesley ChapelUnited StatesUnknown status
Salt Lake Retina
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West JordanUnited StatesUnknown status
Center for Retina and Macula Disease
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Winter HavenUnited StatesUnknown status

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