Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Allergan
With
Molecular Partners AG
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female age 18 years or older
Macular edema due to diabetic retinopathy
Best-corrected visual acuity in the study eye of 20/40 to 20/400
Central subfield thickness ≥ 250 microns by OCT
Females of childbearing potential must have a negative serum pregnancy test at Screening
Male subjects must or be: 1) surgically sterilized for at least 6 months, or 2) use an appropriate method of barrier contraception (e.g., condoms with spermicide) and advise any sexual partner of child-bearing potential that she must also use a reliable method of contraception (e.g., hormonal contraceptive, intrauterine device, diaphragm with spermicide) during the study and for 30 days from study drug administration.
Ability to understand the nature of the study and give written informed consent
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
You may not be if
Any indication of irreversible vision loss such as significant atrophy, scarring, fibrosis, or hyperpigmentation in the fovea
Presence of significant ocular abnormalities in the study eye that prevent retinal assessment, including media opacities, cataract, or inadequate papillary dilation
Presence of vision loss from another ocular disease other than DME
History of any intraocular surgery within 3 months of Baseline
History of intraocular injection of anti-VEGF agent or steroids within 3 months of Baseline
History of laser photocoagulation for macular edema within 4 months prior to Baseline
Uncontrolled hypertension \> 140 systolic or \> 95 diastolic
White blood cells (WBC), hematocrit, and platelets: \< lower limit of normal (LLN)
Heart rate \< 60 beats per minute (bpm) or history of clinically significant bradycardia
History of human immunodeficiency virus (HIV), chronic hepatitis B, or chronic hepatitis C infections
Subjects with infections requiring hospitalization and/or antibiotic treatment 14 days prior to Baseline
Subjects with any medical condition that in the judgment of the investigator could poise unacceptable risk to the subject or compromise interpretation of the data to be collected
Clareo Health | Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
