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

Description

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.

Conditions

Diabetic Macular Edema

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Diabetic Macular Edema
Intervention / Treatment

-

Contacts and Locations

Peoria

Retinal Consultants of AZ, Ltd, Peoria, Arizona, United States, 85381

Phoenix

Associated Retina Consultants, Phoenix, Arizona, United States, 85020

Modesto

Retinal Consultants Medical Group, Modesto, California, United States, 95356

Walnut Creek

Bay Area Retina Associates, Walnut Creek, California, United States, 94598

Melbourne

Florida Eye Associates, Melbourne, Florida, United States, 32901

Hagerstown

Cumberland Valley Retina PC, Hagerstown, Maryland, United States, 21740

Grand Blanc

Retina Associates of Michigan, Grand Blanc, Michigan, United States, 48439-8301

Buffalo

Ross Eye Institute, Buffalo, New York, United States, 14209-2102

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44106

Erie

Erie Retinal Surgery, Erie, Pennsylvania, United States, 16507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * HbA1c ≥ 12% at screening
  • * Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1
  • * History of vitreoretinal surgery/pars plana vitrectomy
  • * Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the study
  • * History of any glaucoma surgery including laser glaucoma procedures
  • * Uncontrolled glaucoma
  • * Any active intra- or periocular infection on Day 1
  • * Any active or history of Intraocular inflammation
  • * Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptor treatment at any time
  • * Any proliferative DR

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2027-04-30