Microplasmin intravitreal administration in patients with vitreomacular traction scheduled for vitrectomy: the MIVI I trial

Marc D de Smet; Arnd Gandorfer; Peter Stalmans; Marc Veckeneer; Eric Feron; Steve Pakola; Anselm Kampik

doi:10.1016/j.ophtha.2009.03.051

Microplasmin intravitreal administration in patients with vitreomacular traction scheduled for vitrectomy: the MIVI I trial

Marc D de Smet, Arnd Gandorfer, Peter Stalmans, Marc Veckeneer, Eric Feron, Steve Pakola, Anselm Kampik

Vitreoretinal surgery

Research output: Contribution to journal › Article › Research › peer-review

Abstract

PURPOSE: To evaluate the safety and preliminary efficacy of 4 doses and several exposure times of intravitreal microplasmin given before pars plana vitrectomy for vitreomacular traction maculopathy.

DESIGN: A multicenter, prospective, uncontrolled, dose-escalation, phase I/II clinical trial.

PARTICIPANTS: Sixty patients enrolled into 6 successive cohorts.

INTERVENTION: A single intravitreal injection of microplasmin at 1 of 4 doses (25, 50, 75, or 125 microg in 100 microl) administered either 1 to 2 hours, 24 hours, or 7 days before planned pars plana vitrectomy.

MAIN OUTCOME MEASURES: For safety, a complete ophthalmologic examination, fundus photography, fluorescein angiography, Humphrey visual fields, and electrophysiology; for efficacy, posterior vitreous detachment (PVD) induction as assessed by B-scan ultrasound and ease of PVD induction at the time of vitrectomy.

RESULTS: The use of microplasmin led to a progressively higher incidence of PVD induction on ultrasonography with increasing time exposure. A PVD before surgery was observed with 25 microg microplasmin in 0, 2, and 5 patients with increasing exposures (2 hours, 24 hours, 7 days). With increasing dose, a PVD before surgery was observed by ultrasound as follows: 25 microg, 0; 50 microg, 1; 75 microg, 2; 125 microg, 3. However, at surgery, with a 125-microg dose, these patients had a discontinuous layer of vitreous present on the retinal surface resulting from the induction of an anomalous PVD in the form of vitreoschisis. One retinal detachment developed shortly after administration of microplasmin. Two developed after surgery. There were no other safety concerns.

CONCLUSIONS: Results from this initial clinical trial evaluating intravitreal microplasmin show the drug to be well tolerated and capable of inducing a pharmacologic PVD in some patients. These results warrant evaluation of microplasmin in larger, controlled trials.

Original language	English
Pages (from-to)	1349-55, 1355.e1-2
Journal	Ophthalmology
Volume	116
Issue number	7
DOIs	https://doi.org/10.1016/j.ophtha.2009.03.051
Publication status	Published - Jul 2009

Keywords

Adult
Aged
Aged, 80 and over
Electrophysiology
Eye Diseases/diagnosis
Female
Fibrinolysin/administration & dosage
Fluorescein Angiography
Humans
Injections
Macula Lutea/drug effects
Male
Middle Aged
Peptide Fragments/administration & dosage
Prospective Studies
Recombinant Proteins/administration & dosage
Retinal Diseases/diagnosis
Ultrasonography
Vitrectomy
Vitreous Body/drug effects
Vitreous Detachment/diagnostic imaging

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10.1016/j.ophtha.2009.03.051

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@article{3db826864ac049948bb09dc140efc74d,

title = "Microplasmin intravitreal administration in patients with vitreomacular traction scheduled for vitrectomy: the MIVI I trial",

abstract = "PURPOSE: To evaluate the safety and preliminary efficacy of 4 doses and several exposure times of intravitreal microplasmin given before pars plana vitrectomy for vitreomacular traction maculopathy.DESIGN: A multicenter, prospective, uncontrolled, dose-escalation, phase I/II clinical trial.PARTICIPANTS: Sixty patients enrolled into 6 successive cohorts.INTERVENTION: A single intravitreal injection of microplasmin at 1 of 4 doses (25, 50, 75, or 125 microg in 100 microl) administered either 1 to 2 hours, 24 hours, or 7 days before planned pars plana vitrectomy.MAIN OUTCOME MEASURES: For safety, a complete ophthalmologic examination, fundus photography, fluorescein angiography, Humphrey visual fields, and electrophysiology; for efficacy, posterior vitreous detachment (PVD) induction as assessed by B-scan ultrasound and ease of PVD induction at the time of vitrectomy.RESULTS: The use of microplasmin led to a progressively higher incidence of PVD induction on ultrasonography with increasing time exposure. A PVD before surgery was observed with 25 microg microplasmin in 0, 2, and 5 patients with increasing exposures (2 hours, 24 hours, 7 days). With increasing dose, a PVD before surgery was observed by ultrasound as follows: 25 microg, 0; 50 microg, 1; 75 microg, 2; 125 microg, 3. However, at surgery, with a 125-microg dose, these patients had a discontinuous layer of vitreous present on the retinal surface resulting from the induction of an anomalous PVD in the form of vitreoschisis. One retinal detachment developed shortly after administration of microplasmin. Two developed after surgery. There were no other safety concerns.CONCLUSIONS: Results from this initial clinical trial evaluating intravitreal microplasmin show the drug to be well tolerated and capable of inducing a pharmacologic PVD in some patients. These results warrant evaluation of microplasmin in larger, controlled trials.",

keywords = "Adult, Aged, Aged, 80 and over, Electrophysiology, Eye Diseases/diagnosis, Female, Fibrinolysin/administration & dosage, Fluorescein Angiography, Humans, Injections, Macula Lutea/drug effects, Male, Middle Aged, Peptide Fragments/administration & dosage, Prospective Studies, Recombinant Proteins/administration & dosage, Retinal Diseases/diagnosis, Ultrasonography, Vitrectomy, Vitreous Body/drug effects, Vitreous Detachment/diagnostic imaging",

author = "{de Smet}, {Marc D} and Arnd Gandorfer and Peter Stalmans and Marc Veckeneer and Eric Feron and Steve Pakola and Anselm Kampik",

year = "2009",

month = jul,

doi = "10.1016/j.ophtha.2009.03.051",

language = "English",

volume = "116",

pages = "1349--55, 1355.e1--2",

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TY - JOUR

T1 - Microplasmin intravitreal administration in patients with vitreomacular traction scheduled for vitrectomy

T2 - the MIVI I trial

AU - de Smet, Marc D

AU - Gandorfer, Arnd

AU - Stalmans, Peter

AU - Veckeneer, Marc

AU - Feron, Eric

AU - Pakola, Steve

AU - Kampik, Anselm

PY - 2009/7

Y1 - 2009/7

N2 - PURPOSE: To evaluate the safety and preliminary efficacy of 4 doses and several exposure times of intravitreal microplasmin given before pars plana vitrectomy for vitreomacular traction maculopathy.DESIGN: A multicenter, prospective, uncontrolled, dose-escalation, phase I/II clinical trial.PARTICIPANTS: Sixty patients enrolled into 6 successive cohorts.INTERVENTION: A single intravitreal injection of microplasmin at 1 of 4 doses (25, 50, 75, or 125 microg in 100 microl) administered either 1 to 2 hours, 24 hours, or 7 days before planned pars plana vitrectomy.MAIN OUTCOME MEASURES: For safety, a complete ophthalmologic examination, fundus photography, fluorescein angiography, Humphrey visual fields, and electrophysiology; for efficacy, posterior vitreous detachment (PVD) induction as assessed by B-scan ultrasound and ease of PVD induction at the time of vitrectomy.RESULTS: The use of microplasmin led to a progressively higher incidence of PVD induction on ultrasonography with increasing time exposure. A PVD before surgery was observed with 25 microg microplasmin in 0, 2, and 5 patients with increasing exposures (2 hours, 24 hours, 7 days). With increasing dose, a PVD before surgery was observed by ultrasound as follows: 25 microg, 0; 50 microg, 1; 75 microg, 2; 125 microg, 3. However, at surgery, with a 125-microg dose, these patients had a discontinuous layer of vitreous present on the retinal surface resulting from the induction of an anomalous PVD in the form of vitreoschisis. One retinal detachment developed shortly after administration of microplasmin. Two developed after surgery. There were no other safety concerns.CONCLUSIONS: Results from this initial clinical trial evaluating intravitreal microplasmin show the drug to be well tolerated and capable of inducing a pharmacologic PVD in some patients. These results warrant evaluation of microplasmin in larger, controlled trials.

AB - PURPOSE: To evaluate the safety and preliminary efficacy of 4 doses and several exposure times of intravitreal microplasmin given before pars plana vitrectomy for vitreomacular traction maculopathy.DESIGN: A multicenter, prospective, uncontrolled, dose-escalation, phase I/II clinical trial.PARTICIPANTS: Sixty patients enrolled into 6 successive cohorts.INTERVENTION: A single intravitreal injection of microplasmin at 1 of 4 doses (25, 50, 75, or 125 microg in 100 microl) administered either 1 to 2 hours, 24 hours, or 7 days before planned pars plana vitrectomy.MAIN OUTCOME MEASURES: For safety, a complete ophthalmologic examination, fundus photography, fluorescein angiography, Humphrey visual fields, and electrophysiology; for efficacy, posterior vitreous detachment (PVD) induction as assessed by B-scan ultrasound and ease of PVD induction at the time of vitrectomy.RESULTS: The use of microplasmin led to a progressively higher incidence of PVD induction on ultrasonography with increasing time exposure. A PVD before surgery was observed with 25 microg microplasmin in 0, 2, and 5 patients with increasing exposures (2 hours, 24 hours, 7 days). With increasing dose, a PVD before surgery was observed by ultrasound as follows: 25 microg, 0; 50 microg, 1; 75 microg, 2; 125 microg, 3. However, at surgery, with a 125-microg dose, these patients had a discontinuous layer of vitreous present on the retinal surface resulting from the induction of an anomalous PVD in the form of vitreoschisis. One retinal detachment developed shortly after administration of microplasmin. Two developed after surgery. There were no other safety concerns.CONCLUSIONS: Results from this initial clinical trial evaluating intravitreal microplasmin show the drug to be well tolerated and capable of inducing a pharmacologic PVD in some patients. These results warrant evaluation of microplasmin in larger, controlled trials.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Electrophysiology

KW - Eye Diseases/diagnosis

KW - Female

KW - Fibrinolysin/administration & dosage

KW - Fluorescein Angiography

KW - Humans

KW - Injections

KW - Macula Lutea/drug effects

KW - Male

KW - Middle Aged

KW - Peptide Fragments/administration & dosage

KW - Prospective Studies

KW - Recombinant Proteins/administration & dosage

KW - Retinal Diseases/diagnosis

KW - Ultrasonography

KW - Vitrectomy

KW - Vitreous Body/drug effects

KW - Vitreous Detachment/diagnostic imaging

U2 - 10.1016/j.ophtha.2009.03.051

DO - 10.1016/j.ophtha.2009.03.051

M3 - Article

C2 - 19447497

SN - 0161-6420

VL - 116

SP - 1349-55, 1355.e1-2

JO - Ophthalmology

JF - Ophthalmology

IS - 7

ER -

Microplasmin intravitreal administration in patients with vitreomacular traction scheduled for vitrectomy: the MIVI I trial

Abstract

Keywords

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