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 |
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).
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
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials