Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR (NCT NCT02681809)

Last Updated: 2020-12-16

Results Overview

Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

Month 3

Results posted on

2020-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Ocriplasmin 0.0625mg Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Ocriplasmin 0.125mg Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	Sham Injection Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
Overall Study STARTED	20	19	9
Overall Study COMPLETED	15	15	8
Overall Study NOT COMPLETED	5	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ocriplasmin 0.0625mg n=20 Participants Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Ocriplasmin 0.125mg n=19 Participants Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	Sham Injection n=9 Participants Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	32 Participants n=4 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	16 Participants n=4 Participants
Age, Continuous	57.7 years STANDARD_DEVIATION 12.14 • n=5 Participants	55.4 years STANDARD_DEVIATION 10.15 • n=7 Participants	54.3 years STANDARD_DEVIATION 13.01 • n=5 Participants	56.2 years STANDARD_DEVIATION 11.39 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	35 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	18 Participants n=7 Participants	7 Participants n=5 Participants	45 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 3

Population: All Treated Subjects with B-scan ultrasound and SD-OCT assessments at Month 3

Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres

Outcome measures

Outcome measures
Measure	Ocriplasmin 0.0625mg n=20 Participants Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Ocriplasmin 0.125mg n=18 Participants Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	Sham Injection n=8 Participants Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
Number of Subjects With Total PVD by the Month 3 Visit	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first injection until the end of the study (Month 24)

Population: All Treated Subjects

Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting

Outcome measures

Outcome measures
Measure	Ocriplasmin 0.0625mg n=20 Participants Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Ocriplasmin 0.125mg n=19 Participants Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	Sham Injection n=9 Participants Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye	15 Participants	14 Participants	4 Participants

Adverse Events

Ocriplasmin 0.0625mg

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Ocriplasmin 0.125mg

Serious events: 8 serious events

Other events: 17 other events

Deaths: 0 deaths

Sham Injection

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Development

ThromboGenics

Phone: +3216751310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right to the 1st publication of the Study results (multi-center publication). Following the 1st publication, PI may publish Study Results. Before submission for publication, Sponsor will be allowed 60 days for review. Sponsor may request to withhold the publication for an additional 60 days. Sponsor reserves the right to remove Confidential Information from the publication and withhold publication if this is not sufficient to protect Intellectual Property Rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Ocriplasmin 0.0625mg n=20 participants at risk Subjects received up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Ocriplasmin 0.125mg n=19 participants at risk Subjects received up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	Sham Injection n=9 participants at risk Subjects received 3 sham injections approximately 1 month apart. No actual injections. No medication was used.
Vascular disorders Peripheral Ischaemia	5.0% 1/20 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	11.1% 1/9 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Injury, poisoning and procedural complications Fibula Fracture	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Injury, poisoning and procedural complications Patella Fracture	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Cardiac disorders Cardiac Failure	5.0% 1/20 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Cardiac disorders Cardiac Failure Congestive	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Blood and lymphatic system disorders Anaemia	5.0% 1/20 • Number of events 2 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Nervous system disorders Cerebrovascular Accident	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Eye disorders Ciliary Zonular Dehiscence	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Eye disorders Retinal Haemorrhage	5.0% 1/20 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Eye disorders Uveitis	5.0% 1/20 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
General disorders Generalised Oedema	5.0% 1/20 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
General disorders Non-Cardiac Chest Pain	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Gastrointestinal disorders Constipation	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 2 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Infections and infestations Respiratory Tract Infection	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 2 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Infections and infestations Abdominal Wall Abscess	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Infections and infestations Catheter Site Cellulitis	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Infections and infestations Cellulitis	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Infections and infestations Endophthalmitis	5.0% 1/20 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/19 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)
Infections and infestations Pneumonia	0.00% 0/20 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	5.3% 1/19 • Number of events 1 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)	0.00% 0/9 • From first injection until the end of the study (Month 24) Adverse events include non-ocular and ocular events (both in study eye and non-study eye)