Trial Outcomes & Findings for Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (NCT NCT00913744)

NCT ID: NCT00913744

Last Updated: 2014-12-17

Results Overview

The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Day 28

Results posted on

2014-12-17

Participant Flow

First subject was enrolled on 29 Jan 2010 and last subject completed the study on 06 Dec 2012

Participant milestones

Participant milestones
Measure	Ocriplasmin Intravitreal injection (125 µg)	Sham Sham injection
Overall Study STARTED	75	25
Overall Study COMPLETED	70	24
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ocriplasmin Intravitreal injection (125 µg)	Sham Sham injection
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	2	1
Overall Study Death	1	0

Baseline Characteristics

Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocriplasmin n=74 Participants Intravitreal injection (125 µg)	Sham n=25 Participants Sham injection	Total n=99 Participants Total of all reporting groups
Age, Continuous	74.5 years STANDARD_DEVIATION 8.13 • n=5 Participants	74.7 years STANDARD_DEVIATION 7.16 • n=7 Participants	74.6 years STANDARD_DEVIATION 7.86 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	15 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	10 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.

The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation

Outcome measures

Outcome measures
Measure	Ocriplasmin n=74 Participants Intravitreal injection (125 µg)	Sham n=25 Participants Sham injection
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28	24.3 percentage of subjects	12.0 percentage of subjects

Adverse Events

Ocriplasmin

Serious events: 18 serious events

Other events: 33 other events

Deaths: 0 deaths

Sham

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Ocriplasmin n=75 participants at risk Intravitreal injection (125 µg)	Sham n=25 participants at risk Sham injection
Eye disorders Visual acuity reduced	16.0% 12/75 • Number of events 17 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	12.0% 3/25 • Number of events 5 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Photopsia	12.0% 9/75 • Number of events 10 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	8.0% 2/25 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Eye pain	13.3% 10/75 • Number of events 10 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	0.00% 0/25 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Conjuctival haemorrhage	9.3% 7/75 • Number of events 8 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	8.0% 2/25 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Retinal haemorrhage	4.0% 3/75 • Number of events 3 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	20.0% 5/25 • Number of events 6 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Vitreous floaters	10.7% 8/75 • Number of events 9 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	0.00% 0/25 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Blepharitis	5.3% 4/75 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	0.00% 0/25 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Cataract nuclear	5.3% 4/75 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	0.00% 0/25 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Corneal oedema	5.3% 4/75 • Number of events 4 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	0.00% 0/25 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Metamorphosia	1.3% 1/75 • Number of events 1 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	8.0% 2/25 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
Eye disorders Ulcerative keratitis	0.00% 0/75 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.	8.0% 2/25 • Number of events 2 • Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection. Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.

Additional Information

Dr. Petra Kozma-Wiebe

ThromboGenics NV

Phone: +32 16 751 310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution and the Principal Investigator (PI) reserve the right to publish only the results of the work performed by the Principal Investigator pursuant to this Agreement; provided, however, that Institution provides Sponsor a copy of any proposed publication, for review and comment at least sixty (60) days in advance of its submission for publication.
Publication restrictions are in place

Restriction type: OTHER