Trial · NCT02681809
A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
NCT02681809, Phase 2, Terminated, ThromboGenics; results first posted 2020-12-16
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR. Trials, record NCT02681809. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02681809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
- NCT number
- NCT02681809
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- ThromboGenics
- Conditions
- Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression
- Interventions
- ocriplasmin 0.0625mg, ocriplasmin 0.125mg, Sham injection
- First posted
- 2016-02-12
- Last updated
- 2020-12-16
- Other registries' IDs
- eudract:2015-002415-15
- Results first posted
- 2020-12-16
- Limitations and caveats
Recruitment in the study was discontinued early due to slow recruitment rate. This led to 48 randomized subjects instead of the planned 115. By consequence, the study was not powered for its primary endpoint, which was evaluated only descriptively.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Total PVD by the Month 3 Visit | 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 |
| Secondary | Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye | From first injection until the end of the study (Month 24) | Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Total PVD by the Month 3 Visit | Month 3 | All Treated Subjects with B-scan ultrasound and SD-OCT assessments at Month 3 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye | From first injection until the end of the study (Month 24) | All Treated Subjects | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Total PVD by the Month 3 Visit | Ocriplasmin 0.0625mg | 0 | Participants | ||
| Number of Subjects With Total PVD by the Month 3 Visit | Ocriplasmin 0.125mg | 0 | Participants | ||
| Number of Subjects With Total PVD by the Month 3 Visit | Sham Injection | 0 | Participants | ||
| Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye | Ocriplasmin 0.0625mg | 15 | Participants | ||
| Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye | Ocriplasmin 0.125mg | 14 | Participants | ||
| Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye | Sham Injection | 4 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ocriplasmin 0.0625mg | 20 | |
| Overall Study | STARTED | Ocriplasmin 0.125mg | 19 | |
| Overall Study | STARTED | Sham Injection | 9 | |
| Overall Study | COMPLETED | Ocriplasmin 0.0625mg | 15 | |
| Overall Study | COMPLETED | Ocriplasmin 0.125mg | 15 | |
| Overall Study | COMPLETED | Sham Injection | 8 | |
| Overall Study | NOT COMPLETED | Ocriplasmin 0.0625mg | 5 | |
| Overall Study | NOT COMPLETED | Ocriplasmin 0.125mg | 4 | |
| Overall Study | NOT COMPLETED | Sham Injection | 1 |
Source ClinicalTrials.gov
Adverse events291
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Ocriplasmin 0.0625mg | 1 | 20 | 1 |
| other | Hypertension | Vascular disorders | Ocriplasmin 0.125mg | 2 | 19 | 3 |
| other | Hypertension | Vascular disorders | Sham Injection | 1 | 9 | 1 |
| other | Deep Vein Thrombosis | Vascular disorders | Ocriplasmin 0.0625mg | 0 | 20 | 0 |
| other | Deep Vein Thrombosis | Vascular disorders | Ocriplasmin 0.125mg | 1 | 19 | 1 |
| other | Deep Vein Thrombosis | Vascular disorders | Sham Injection | 0 | 9 | 0 |
| other | Hypertensive Crisis | Vascular disorders | Ocriplasmin 0.0625mg | 0 | 20 | 0 |
| other | Hypertensive Crisis | Vascular disorders | Ocriplasmin 0.125mg | 1 | 19 | 1 |
| other | Hypertensive Crisis | Vascular disorders | Sham Injection | 0 | 9 | 0 |
| other | Peripheral Ischaemia | Vascular disorders | Ocriplasmin 0.0625mg | 1 | 20 | 2 |
1 to 10 of 291Source ClinicalTrials.gov
See all 291 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ocriplasmin 0.0625mg | 0 | 20 |
| Total, all-cause mortality | Ocriplasmin 0.125mg | 0 | 19 |
| Total, all-cause mortality | Sham Injection | 0 | 9 |
| Total, other adverse events | Ocriplasmin 0.0625mg | 16 | 20 |
| Total, other adverse events | Ocriplasmin 0.125mg | 17 | 19 |
| Total, other adverse events | Sham Injection | 7 | 9 |
| Total, serious adverse events | Ocriplasmin 0.0625mg | 5 | 20 |
| Total, serious adverse events | Ocriplasmin 0.125mg | 8 | 19 |
| Total, serious adverse events | Sham Injection | 1 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02681809
GET https://conductscience.org/api/trials/v1/NCT02681809/events?page=2