Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of diabetes mellitus (Type 1 or Type 2)
Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
Decreased visual acuity attributable primarily to DME
Ability and willingness to provide written informed consent and to comply with the study protocol
Willingness to allow Aqueous Humor collection
For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of \<1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
You may not be if
Hemoglobin A1c (HbA1c) of greater than (\>) 12%
Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
Currently pregnant or breastfeeding, or intend to become pregnant during the study
Prior treatment with panretinal photocoagulation or macular laser to the study eye
Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo\^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: \</=24 weeks prior to Day 1) in either eye
Any proliferative diabetic retinopathy
Active intraocular or periocular infection or active intraocular inflammation in the study eye
Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
Clareo Health | A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
