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

Macular Degeneration Clinical Trial

— AMD  

Official title:

Resolution of Vitreomacular Adhesion (VMA) Associated With Neovascular Age Related Macular Degeneration (AMD) With Intravitreal Microplasmin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00996684
• Other study ID #: JSEI-TG-AMD-001
• Status: Recruiting
• Phase: Phase 2
• First received: October 15, 2009
• Last updated: September 26, 2011
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2011
• Source: University of California, Los Angeles
• Contact: Rosaleen M Ostrick, MPH, MA
• Phone: 310-794-5595
• Email: ostrick[@]jsei.ucla.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Microplasmin
Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0.
• Placebo control
The placebo control will be the microplasmin vehicle without the microplasmin.

Locations

Country	Name	City	State
United States	Jules Stein Eye Institute/UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is the proportion of patients in whom there is release of vitreomacular traction as assessed by ultrasonography, optical coherence tomography and physical examination		Day 28	No
Secondary	Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD		12 months	No
Secondary	Change in mean macular thickness		Day 28 and month 12	No
Secondary	Mean change in ETDRS visual acuity		Day 28 and Month 12	No
Secondary	Incidence and severity of ocular adverse events		Day 28 and Month 12	Yes
Secondary	Incidence and severity of nonocular adverse events		Day 28 and Month 12	Yes