Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration

NCT ID: NCT00996684

Last Updated: 2011-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-12-31

Brief Summary

The purpose of this study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)

Detailed Description

The human vitreous gel undergoes progressive liquefaction with age. Concurrent with the process of vitreous liquefaction, there is a weakening of the adhesion at the vitreoretinal interface between the cortical vitreous gel and the inner limiting lamina. Posterior vitreous detachment (PVD) is a separation of the cortical vitreous get from the inner limiting lamina. PVD is usually a sudden event during which liquefied vitreous from the center of the vitreous body bursts through a hole in the posterior vitreous cortex and then dissects the residual cortex gel away from the inner limiting lamina. If there is residual vitreoretinal traction around the break, this process may induce a tear in the retina that can in turn result in rhegmatogenous retinal detachment, macular hole, or cystoid macular edema. The importance of the vitreous in the progression of diabetic retinopathy may also extend beyond tractional considerations. For example, it is believed that the vitreous serves as scaffolding for new vessel formation and may also contribute to molecular imbalances that lead to retinopathy progression. Therefore, total PVD, by releasing vitreoretinal traction as well as other potential mechanisms, may be beneficial in various vitreoretinal diseases such as neovascular AMD.

Vitreomacular adhesion (VMA) in exudative (wet) AMD may be associated with poor prognosis in patients with AMD. This trial is primarily aimed at showing that release of VMA can be induced by microplasmin, a proteolytic enzyme, in patients with wet AMD, and that microplasmin is safe in patients w/ neovascular (wet) AMD. Secondary endpoint will be assessment of improved AMD outcomes.

Conditions

Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

microplasmin, intravitreal injection

Subjects will receive one intravitreal injection of microplasmin on Day 0.

Group Type: EXPERIMENTAL

Microplasmin

Intervention Type: DRUG

Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.

Placebo

Subjects will receive one intravitreal injection of the placebo on Day 0.

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: DRUG

The placebo control will be the microplasmin vehicle without the microplasmin.

Interventions

Microplasmin

Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.

Intervention Type: DRUG

Placebo control

The placebo control will be the microplasmin vehicle without the microplasmin.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged 50 years or older
• Presence of focal vitreomacular adhesion as seen by OCT
• BCVA of 20/800 or better in non-study eye
• Presence of active choroidal neovascular membrane
• Written informed consent obtained from subject prior to inclusion in the trial

Exclusion Criteria

• Subjects who have previously received microplasmin
• Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes adequate examination or investigation of study eye
• Patient with uncontrolled glaucoma including IOP >25 mm Hg
• Subjects who have had vitrectomy or retinal detachment or who are aphakic or highly myopic (>8.0 D) in the study eye
• Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods include intrauterine device, oral, implanted or injected contraceptives, and barrier methods with spermicide.
• Subjects who, in the Investigator's view, will not complete all visits and investigations
• Patient who have PDT or any intravitreal injection in the last 10 days. Patients who in the examiners opinion will need intravitreal injection in the next 10 days (apart from microplasmin).
• Patients who have participated in an investigational drug trial in the past 30 days.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ThromboGenics

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Steven Schwartz

Chief, Retina Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven D Schwartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Jules Stein Eye Institute/UCLA

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosaleen M Ostrick, MPH, MA

Role: CONTACT

ostrick@jsei.ucla.edu

310-794-5595

Logan Hitchcock, B.S.

Role: CONTACT

hitchcock@jsei.ucla.edu

310-794-5596

Other Identifiers

JSEI-TG-AMD-001

Identifier Type: -

Identifier Source: org_study_id