A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
