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

NCT02681809 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-12-16

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).

Conditions

Interventions

DRUG

ocriplasmin 0.0625mg

Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart

DRUG

ocriplasmin 0.125mg

Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart

DRUG

Sham injection

3 sham injections approximately 1 month apart. No actual injections. No medication is used.

Sponsors & Collaborators

  • ThromboGenics

    lead INDUSTRY

Principal Investigators

  • Clinical Department · ThromboGenics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-11-18
Completion
2019-11-18

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02681809 on ClinicalTrials.gov