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Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MP0112
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilmer Eye Institute
  • Ophthalmic Consultants of Boston
  • Retina Research Center
  • Retina Consultants of Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

MP0112 (0.04 mg)

MP0112 (0.15 mg)

MP0112 (0.4 mg)

MP0112 (1.0 mg)

MP0112 (2.0 mg)

MP0112 (3.6 mg)

Arm Description

Single 0.04 mg intravitreal injection of MP0112 in the study eye.

Single 0.15 mg intravitreal injection of MP0112 in the study eye.

Single 0.4 mg intravitreal injection of MP0112 in the study eye.

Single 1.0 mg intravitreal injection of MP0112 in the study eye.

Single 2.0 mg intravitreal injection of MP0112 in the study eye.

Single 3.6 mg intravitreal injection of MP0112 in the study eye.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.

Full Information

First Posted
January 1, 2010
Last Updated
April 14, 2014
Sponsor
Allergan
Collaborators
Molecular Partners AG
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1. Study Identification

Unique Protocol Identification Number
NCT01042678
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to a company decision.
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
Molecular Partners AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MP0112 (0.04 mg)
Arm Type
Experimental
Arm Description
Single 0.04 mg intravitreal injection of MP0112 in the study eye.
Arm Title
MP0112 (0.15 mg)
Arm Type
Experimental
Arm Description
Single 0.15 mg intravitreal injection of MP0112 in the study eye.
Arm Title
MP0112 (0.4 mg)
Arm Type
Experimental
Arm Description
Single 0.4 mg intravitreal injection of MP0112 in the study eye.
Arm Title
MP0112 (1.0 mg)
Arm Type
Experimental
Arm Description
Single 1.0 mg intravitreal injection of MP0112 in the study eye.
Arm Title
MP0112 (2.0 mg)
Arm Type
Experimental
Arm Description
Single 2.0 mg intravitreal injection of MP0112 in the study eye.
Arm Title
MP0112 (3.6 mg)
Arm Type
Experimental
Arm Description
Single 3.6 mg intravitreal injection of MP0112 in the study eye.
Intervention Type
Biological
Intervention Name(s)
MP0112
Intervention Description
Single intravitreal injection of MP0112 in the study eye
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Best-Corrected Visual Acuity (BCVA)
Description
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.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)
Description
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).
Time Frame
Baseline, Week 16
Title
Serum Levels of MP0112
Description
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.
Time Frame
16 Weeks
Title
Aqueous Humor Levels of MP0112
Description
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.
Time Frame
1 Week
Title
Number of Participants With Positive Binding Anti-MP0112 Antibodies
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

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