Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: MP0112
Intervention description: Single intravitreal injection of MP0112 in the study eye
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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