Trial Outcomes & Findings for A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME) (NCT NCT00412451)

Last Updated: 2014-12-17

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Day 14 post-injection

Results posted on

2014-12-17

Participant Flow

The first patient was enrolled on 15 December 2006 and the last patient completed the last visit on 19 January 2010. All patients were selected in medical clinics

The trial investigated 3 doses: 25, 75 and 125µg in 3 consecutive cohorts. Patients in each cohort were to be randomized to active treatment or sham injection in a 3:1 ratio. Enrolment into the high dose microplasmin groups was to start only after acceptable safety had been achieved with the previous doses as determined by a Study Safety Committee.

Participant milestones

Participant milestones
Measure	Ocriplasmin 25µg 25µg ocriplasmin intravitreal injections versus sham injection	Ocriplasmin 75µg 75µg ocriplasmin intravitreal injection versus sham injection	0criplasmin 125µg 125µg ocriplasmin intravitreal injection versus sham injection	Sham Injection Sham intravitreal injection
Overall Study STARTED	8	15	15	13
Overall Study COMPLETED	8	15	14	11
Overall Study NOT COMPLETED	0	0	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocriplasmin 25µg n=8 Participants 25µg ocriplasmin intravitreal injection versus sham injection	Ocriplasmin 75µg n=15 Participants 75µg ocriplasmin intravitreal injection versus sham injection	Ocriplasmin 125µg n=15 Participants 125µg ocriplasmin intravitreal injection versus sham injection	Sham Injection n=13 Participants Sham injection Sham injection : Sham intravitreal injection	Total n=51 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	67.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	61.7 years STANDARD_DEVIATION 13.4 • n=5 Participants	69.9 years STANDARD_DEVIATION 6.2 • n=4 Participants	63.9 years STANDARD_DEVIATION 11.1 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	9 Participants n=4 Participants	32 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 14 post-injection

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

Outcome measures

Outcome measures
Measure	Ocriplasmin 25µg n=8 Participants 25µg ocriplasmin intravitreal injection versus sham injection	Ocriplasmin 75µg n=15 Participants 75µg ocriplasmin intravitreal injection versus sham injection	Ocriplasmin 125µg n=15 Participants 125µg ocriplasmin intravitreal injection versus sham injection	Sham Injection n=13 Participants Sham injection Sham injection : Sham intravitreal injection
PVD Induction	0 percentage of participants	20 percentage of participants	13.3 percentage of participants	30.8 percentage of participants

Adverse Events

Ocriplasmin 25µg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Ocriplasmin 75µg

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Ocriplasmin 125µg

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham Injection

Serious events: 9 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Petra Kozma-Wiebe, MD

ThromboGenics NV

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 25µg n=8 participants at risk 25µg ocriplasmin intravitreal injection versus sham injection	Ocriplasmin 75µg n=15 participants at risk 75µg ocriplasmin intravitreal injection versus sham injection	Ocriplasmin 125µg n=15 participants at risk 125µg ocriplasmin intravitreal injection versus sham injection	Sham Injection n=13 participants at risk Sham injection Sham injection : Sham intravitreal injection
Eye disorders maculopathy	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Cardiac disorders Angina pectoris	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Cardiac disorders Atrioventricular block complete	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Cardiac disorders Cardiac arrest	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Cardiac disorders Myocardial infaction	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Cardiac disorders Myocardial ischaemia	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Gastrointestinal disorders Intestinal obstruction	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Eye disorders Macular oedema	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Eye disorders Optic disc vascular disorder	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Eye disorders Retinal artery occlusion	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Infections and infestations Urosepsis	12.5% 1/8 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	7.7% 1/13 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Nervous system disorders Monoparesis	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Vascular disorders Haematoma	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Vascular disorders Hypovolaemic shock	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection
Vascular disorders Thrombosis	0.00% 0/8 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/15 • AEs/SAEs were collected from injection day up to Month 12 post-injection	6.7% 1/15 • Number of events 1 • AEs/SAEs were collected from injection day up to Month 12 post-injection	0.00% 0/13 • AEs/SAEs were collected from injection day up to Month 12 post-injection