Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

A Phase I/II, Open-label, Single Ascending Dose Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of Intravitreal MP0112 in Patients With Diabetic Macular Edema (DME)

The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with diabetic retinal edema.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• HbA1C ≥ 12%
• Creatinine: > 1.5 x upper limit of normal (ULN)
• Alanine transaminase (ALT), aspartate transaminase (AST), and gamma-glutamyl transferase (GGT): > ULN
• 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