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



Status:Active, not recruiting
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:December 2015
End Date:December 2019

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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)

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).


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
We found this trial at
10
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2537
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from 02139
Loma Linda, CA
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Brno,
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Campbell, CA
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Charlottesville, VA
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Irvine, CA
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McAllen, TX
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Phoenix, AZ
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1610
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Rapid City, SD
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1769
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San Antonio, TX
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2578
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Santa Ana, CA
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