Clinical trial NCT01042678: Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: Molecular Partners AG
First posted: 2010-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 16 weeks
Secondary outcomes:
measure: Best-Corrected Visual Acuity (BCVA)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, Week 16
measure: Serum Levels of MP0112
timeFrame: 16 Weeks
measure: Aqueous Humor Levels of MP0112
timeFrame: 1 Week
measure: Number of Participants With Positive Binding Anti-MP0112 Antibodies
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
Study officials:
References: