A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

Overview

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.

Full Title of Study: “A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of DME.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: ocriplasmin
    • Intravitreal injection, single administration
  • Other: Sham injection
    • Sham intravitreal injection

Arms, Groups and Cohorts

  • Experimental: Ocriplasmin 25µg
    • 25µg ocriplasmin intravitreal injection versus sham injection
  • Experimental: Ocriplasmin 75µg
    • 75µg ocriplasmin intravitreal injection versus sham injection
  • Experimental: Ocriplasmin 125µg
    • 125µg ocriplasmin intravitreal injection versus sham injection
  • Sham Comparator: sham injection
    • Sham injection

Clinical Trial Outcome Measures

Primary Measures

  • PVD Induction
    • Time Frame: Day 14 post-injection
    • The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)

Participating in This Clinical Trial

Inclusion Criteria include:

  • patients >18 years of age with Diabetic Macular Edema

Exclusion Criteria include:

  • PVD present at baseline
  • Vitreous hemorrhage
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • Patients who have had a vitrectomy in the study eye at any time

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ThromboGenics
  • Provider of Information About this Clinical Study
    • Sponsor

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