Study of MP0112 Intravitreal Injection in Patients With Diabetic Macular Edema

NCT ID: NCT01042678

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MP0112 (0.04 mg)

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

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

MP0112 (0.15 mg)

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

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

MP0112 (0.4 mg)

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

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

MP0112 (1.0 mg)

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

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

MP0112 (2.0 mg)

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

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

MP0112 (3.6 mg)

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

Group Type: EXPERIMENTAL

MP0112

Intervention Type: BIOLOGICAL

Single intravitreal injection of MP0112 in the study eye

Interventions

MP0112

Single intravitreal injection of MP0112 in the study eye

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molecular Partners AG

INDUSTRY

Sponsor Role: collaborator

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wilmer Eye Institute

Baltimore, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Retina Research Center

Austin, Texas, United States

Retina Consultants of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

MP0112-CP02

Identifier Type: -

Identifier Source: org_study_id