Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01042678
• Other study ID #: MP0112-CP02
• Status: Terminated
• Phase: Phase 1
• First received: January 1, 2010
• Last updated: April 14, 2014
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Biological:
• MP0112
Single intravitreal injection of MP0112 in the study eye

Locations

Country	Name	City	State
United States	Retina Research Center	Austin	Texas
United States	Wilmer Eye Institute	Baltimore	Maryland
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Retina Consultants of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	Molecular Partners AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.	16 weeks	Yes
Secondary	Best-Corrected Visual Acuity (BCVA)	BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision.	Baseline, Week 16	No
Secondary	Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)	Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).	Baseline, Week 16	No
Secondary	Serum Levels of MP0112	Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.	16 Weeks	No
Secondary	Aqueous Humor Levels of MP0112	Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.	1 Week	No
Secondary	Number of Participants With Positive Binding Anti-MP0112 Antibodies	Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.	12 weeks	No