Clinical trial NCT02681809: A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Posterior Vitreous Detachment
Disease Progression
Lead sponsor: Oxurion
Sponsor class: INDUSTRY
First posted: 2016-02-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Subjects With Total PVD by the Month 3 Visit
timeFrame: Month 3
Secondary outcomes:
measure: Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
timeFrame: From first injection until the end of the study (Month 24)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Campbell
country: United States
state: California
city: Irvine
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Rapid City
country: United States
state: South Dakota
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Olomouc
country: Czechia
city: Pardubice
country: Czechia
city: Praha 10
country: Czechia
city: Praha 4
country: Czechia
city: Zlin
country: Czechia
city: Paris
country: France
city: Munchen
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Leipzig
country: Germany
state: Sachsen
city: Debrecen
country: Hungary
state: Hajdú-Bihar
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Szombathely
country: Hungary
city: Be'er Sheva'
country: Israel
city: Petah Tiqva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Milan
country: Italy
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Valladolid
country: Spain
city: Frimley
country: United Kingdom
state: Surrey
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: ThromboGenics
name: Clinical Department
role: STUDY_DIRECTOR
References: