Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

NCT01042678 | Terminated Phase 1 Results DMC

• 1 other identifier: MP0112-CP02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Best-Corrected Visual Acuity (BCVA)

  Baseline, Week 16

• Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)

  Baseline, Week 16

• Serum Levels of MP0112

  16 Weeks

• Aqueous Humor Levels of MP0112

  1 Week

• Number of Participants With Positive Binding Anti-MP0112 Antibodies

  12 weeks

Study Arms (6)

MP0112 (0.04 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (0.15 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (0.4 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (1.0 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (2.0 mg)

EXPERIMENTAL

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

Biological: MP0112

MP0112 (3.6 mg)

EXPERIMENTAL

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

Biological: MP0112

Interventions

MP0112 BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

MP0112 (0.04 mg); MP0112 (0.15 mg); MP0112 (0.4 mg); MP0112 (1.0 mg); MP0112 (2.0 mg); MP0112 (3.6 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead
• Molecular Partners AG: collaborator

Study Sites (4)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

MP0112

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2010
• First Posted: January 5, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04

Locations

US (4)