Text Size

Study of MP0112 Intravitreal Injection in Patients With Diabetic Macula 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: November 21, 2011
Last verified: November 2011
History of Changes
  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:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Safety and tolerability, Safety assessments will be done for 16 weeks after intraocular injection of MP0112. Hematology and blood chemistry tests will be done at baseline and 4 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change from baseline in best-corrected visual acuity (BCVA) over 16 weeks after injection of MP0112. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Biological: MP0112
    DARPin
  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
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
Last Updated: November 21, 2011
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 May 23, 2013