NCT02681809

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

A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: ThromboGenics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Diabetic Retinopathy
• Posterior Vitreous Detachment
• Disease Progression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-11-18
• Completion: 2019-11-18
• First posted: 2016-02-12
• Last updated: 2020-12-16
• Results posted: 2020-12-16

Locations

38 sites across 9 countries: United States, Czechia, France, Germany, Hungary, Israel, Italy, Spain, United Kingdom