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

T

ThromboGenics

Status and phase

Terminated
Phase 2

Conditions

Disease Progression
Posterior Vitreous Detachment
Diabetic Retinopathy

Treatments

Drug: Sham injection
Drug: ocriplasmin 0.125mg
Drug: ocriplasmin 0.0625mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02681809
TG-MV-015
2015-002415-15 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 3 patient groups

Ocriplasmin 0.0625mg
Experimental group
Treatment:
Drug: ocriplasmin 0.0625mg
Ocriplasmin 0.125mg
Experimental group
Treatment:
Drug: ocriplasmin 0.125mg
Sham injection
Sham Comparator group
Treatment:
Drug: Sham injection

Trial documents
2

Trial contacts and locations

38

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Data sourced from clinicaltrials.gov

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