Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

This study has been terminated.
(The study was terminated due to a company decision.)
Sponsor:
Collaborator:
Molecular Partners AG
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01042678
First received: January 1, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Biological: MP0112
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Best-Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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).

  • Serum Levels of MP0112 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    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.

  • Aqueous Humor Levels of MP0112 [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Positive Binding Anti-MP0112 Antibodies [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MP0112 (0.04 mg)
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye
Experimental: MP0112 (0.15 mg)
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye
Experimental: MP0112 (0.4 mg)
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye
Experimental: MP0112 (1.0 mg)
Single 1.0 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye
Experimental: MP0112 (2.0 mg)
Single 2.0 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye
Experimental: MP0112 (3.6 mg)
Single 3.6 mg intravitreal injection of MP0112 in the study eye.
Biological: MP0112
Single intravitreal injection of MP0112 in the study eye

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042678

Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Texas
Retina Research Center
Austin, Texas, United States, 78705
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Allergan
Molecular Partners AG
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01042678     History of Changes
Other Study ID Numbers: MP0112-CP02
Study First Received: January 1, 2010
Results First Received: April 14, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014