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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression

In brief

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).

Key facts

Study ID

NCT02681809

Run by

ThromboGenics

People needed

48

Starts

2015-12-01

Expected to finish

2019-11-18

Last updated by the study team

2020-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18 years or older
• 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

You may not qualify if…

• History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Campbell, California, United States
• Study site — Irvine, California, United States
• Study site — Loma Linda, California, United States
• Study site — Santa Ana, California, United States
• Study site — Rapid City, South Dakota, United States
• Study site — McAllen, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Brno, Czechia
• Study site — Hradec Králové, Czechia
• Study site — Olomouc, Czechia
• Study site — Pardubice, Czechia
• Study site — Prague, Czechia
• Study site — Prague, Czechia
• Study site — Zlín, Czechia
• Study site — Paris, France
• Study site — München, Bavaria, Germany
• Study site — Darmstadt, Hesse, Germany
• Study site — Leipzig, Saxony, Germany
• Study site — Debrecen, Hajdú-Bihar, Hungary
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary
• Study site — Budapest, Hungary

Full record on ClinicalTrials.gov

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