Trial Outcomes & Findings for Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial. (NCT NCT00781859)

Last Updated: 2014-12-17

Results Overview

The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

326 participants

Primary outcome timeframe

Day 28

Results posted on

2014-12-17

Participant Flow

First patient was recruited on 30 Dec 2008 and last patient completed the study on 17 March 2010

Participant milestones

Participant milestones
Measure	Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection	Placebo Intravitreal injection of placebo
Overall Study STARTED	219	107
Overall Study COMPLETED	200	98
Overall Study NOT COMPLETED	19	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocriplasmin 125µg 125µg ocriplasmin intravitreal injection	Placebo Intravitreal injection of placebo
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	8	4
Overall Study Lost to Follow-up	6	3
Overall Study Death	3	0

Baseline Characteristics

Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocriplasmin 125µg n=219 Participants 125µg microplasmin intravitreal injection	Placebo n=107 Participants Intravitreal injection of placebo	Total n=326 Participants Total of all reporting groups
Age, Continuous	71.5 years STANDARD_DEVIATION 10.25 • n=5 Participants	71.1 years STANDARD_DEVIATION 10.04 • n=7 Participants	71.3 years STANDARD_DEVIATION 10.17 • n=5 Participants
Sex: Female, Male Female	148 Participants n=5 Participants	59 Participants n=7 Participants	207 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	48 Participants n=7 Participants	119 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Intention-To-Treat (ITT), Last Observation Carried forward (LOCF)

Outcome measures

Outcome measures
Measure	Ocriplasmin 125µg n=219 Participants 125µg ocriplasmin intravitreal injection	Placebo n=107 Participants Intravitreal injection of placebo
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.	27.9 percentage of participants	13.1 percentage of participants

SECONDARY outcome

Timeframe: Day 28

Population: Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF)

The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.

Outcome measures

Outcome measures
Measure	Ocriplasmin 125µg n=219 Participants 125µg ocriplasmin intravitreal injection	Placebo n=107 Participants Intravitreal injection of placebo
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28	16.4 percentage of participants	6.5 percentage of participants

Adverse Events

Ocriplasmin 125µg

Serious events: 32 serious events

Other events: 127 other events

Deaths: 0 deaths

Placebo

Serious events: 13 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ocriplasmin 125µg n=220 participants at risk 125µg ocriplasmin intravitreal injection	Placebo n=106 participants at risk Intravitreal injection of placebo
Eye disorders Intraocular pressure incresed	4.1% 9/220 • Number of events 9 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	9.4% 10/106 • Number of events 10 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Vitreous floaters	20.0% 44/220 • Number of events 49 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	9.4% 10/106 • Number of events 10 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Conjunctival Hemorrhage	15.5% 34/220 • Number of events 35 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	13.2% 14/106 • Number of events 14 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Photopsia	16.8% 37/220 • Number of events 40 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	3.8% 4/106 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Eye pain	15.5% 34/220 • Number of events 39 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	5.7% 6/106 • Number of events 6 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Vision blurred	11.4% 25/220 • Number of events 27 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	4.7% 5/106 • Number of events 7 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Visual impairment	9.5% 21/220 • Number of events 23 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	2.8% 3/106 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Visual acuity reduced	6.4% 14/220 • Number of events 15 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	5.7% 6/106 • Number of events 6 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Photophobia	6.4% 14/220 • Number of events 14 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Retinal edema	5.9% 13/220 • Number of events 14 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.94% 1/106 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.

Additional Information

Petra Kozma-Wiebe

ThromboGenics

Phone: +32 16751310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Ocriplasmin 125µg n=220 participants at risk 125µg ocriplasmin intravitreal injection	Placebo n=106 participants at risk Intravitreal injection of placebo
Eye disorders Macular hole	7.3% 16/220 • Number of events 17 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	10.4% 11/106 • Number of events 11 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Retinal detachment	0.91% 2/220 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	1.9% 2/106 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Maculopathy	1.4% 3/220 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Eye disorders Visual acuity reduced	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Gastrointestinal disorders Small intestinal obstruction	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Gastrointestinal disorders Upper gastrointestinal hemorrahge	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Injury, poisoning and procedural complications Femur fracture	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Injury, poisoning and procedural complications Upper limb fracture	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Cardiac disorders Cardiac failure congestive	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Infections and infestations Pneumonia	0.00% 0/220 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.94% 1/106 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/220 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.94% 1/106 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Nervous system disorders Cerebral hemorrahge	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Psychiatric disorders Anxiety	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.
Renal and urinary disorders Renal failure acute	0.45% 1/220 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.	0.00% 0/106 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection. AEs/SAEs were assessed by the investigator at all study visits.