NCT00412451

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Typical duration for phase_2

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2013

Completed
Last Updated

December 17, 2014

Status Verified

April 1, 2014

Enrollment Period

3.1 years

First QC Date

December 14, 2006

Results QC Date

July 4, 2013

Last Update Submit

December 2, 2014

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular EdemaPVDDMEDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • PVD Induction

    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)

    Day 14 post-injection

Study Arms (4)

Ocriplasmin 25µg

EXPERIMENTAL

25µg ocriplasmin intravitreal injection versus sham injection

Drug: ocriplasmin

Ocriplasmin 75µg

EXPERIMENTAL

75µg ocriplasmin intravitreal injection versus sham injection

Drug: ocriplasmin

Ocriplasmin 125µg

EXPERIMENTAL

125µg ocriplasmin intravitreal injection versus sham injection

Drug: ocriplasmin

sham injection

SHAM COMPARATOR

Sham injection

Other: Sham injection

Interventions

ocriplasminDRUG

Intravitreal injection, single administration

Also known as: microplasmin
Ocriplasmin 125µgOcriplasmin 25µgOcriplasmin 75µg
Sham injectionOTHER

Sham intravitreal injection

sham injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients \>18 years of age with Diabetic Macular Edema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

ZNA OCMW Antwerpen

Antwerp, 2020, Belgium

Location

University Hospital of Ghent

Ghent, B-9000, Belgium

Location

University Hospital Leuven

Leuven, Belgium

Location

Ludwig Maximillian University

Munich, Germany

Location

University of Milan

Milan, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, Italy

Location

Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart

Rome, 00168, Italy

Location

Ospedale di Circolo di Varese, Insubria University

Varese, 21100, Italy

Location

Academic Hospital Groningen

Groningen, 9700 RB, Netherlands

Location

Het Oogziekenhuis Rotterdam

Rotterdam, 3011 BH, Netherlands

Location

Institut de Microcirurgia Ocular de Barcelona

Barcelona, 08022, Spain

Location

Hospital Vall D'Hebron

Barcelona, 08035, Spain

Location

Instituto Technologico de Oftalmologia SL.

Santiago de Compostela, Spain

Location

Royal Liverpool & Broadgreen Hospital

Liverpool, L7 8XP, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

microplasminsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Results Point of Contact

Title
Petra Kozma-Wiebe, MD
Organization
ThromboGenics NV
petra.kozma@thrombogenics.com
+32 16751310

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 18, 2006

Study Start

December 1, 2006

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

December 17, 2014

Results First Posted

September 13, 2013

Record last verified: 2014-04

Locations

BE(3)GB(2)IT(4)ES(3)DE(1)NL(2)