A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
NCT ID: NCT02681809
Last Updated: 2020-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
48 participants
INTERVENTIONAL
2015-12-31
2019-11-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ocriplasmin 0.0625mg
ocriplasmin 0.0625mg
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
Ocriplasmin 0.125mg
ocriplasmin 0.125mg
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
Sham injection
Sham injection
3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ocriplasmin 0.0625mg
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
ocriplasmin 0.125mg
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
Sham injection
3 sham injections approximately 1 month apart. No actual injections. No medication is used.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
* HbA1c ≤ 12%, as assessed by the central laboratory
* Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
* Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema
* No evidence of total PVD in the study eye
* Written informed consent obtained from the subject prior to screening procedures
Exclusion Criteria
* Presence of epiretinal membrane in the study eye
* Presence of foveal ischemia in the study eye
* Presence of pre-retinal or vitreous haemorrhage in the study eye
* Presence of iris or angle neovascularisation in the study eye
* Any active ocular / intraocular infection or inflammation in either eye
* Aphakic study eye
* Uncontrolled hypertension in the opinion of the Investigator
* Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ThromboGenics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Department
Role: STUDY_DIRECTOR
ThromboGenics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Campbell, California, United States
Irvine, California, United States
Loma Linda, California, United States
Santa Ana, California, United States
Rapid City, South Dakota, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Prague, , Czechia
Zlín, , Czechia
Paris, , France
München, Bavaria, Germany
Darmstadt, Hesse, Germany
Leipzig, Saxony, Germany
Debrecen, Hajdú-Bihar, Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Szombathely, , Hungary
Beersheba, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Milan, , Italy
Barcelona, , Spain
Barcelona, , Spain
Girona, , Spain
Valladolid, , Spain
Frimley, Surrey, United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-002415-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TG-MV-015
Identifier Type: -
Identifier Source: org_study_id