Moderately severe to very severe non-proliferative diabetic retinopathy (NPDR) MedDRA version: 18.1 Level: LLT Classification code 10054109 Term: Non-proliferative diabetic retinopathy System Organ Class: 100000004853
Conditions
Interventions
Trade Name: JETREA 0.5 mg/0.2 mL concentrate for solution for injection
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: OCRIPLASMIN
CAS Number: 1048016-09-6
Concentrat
Sponsors
ThromboGenics NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged 18 years or older - BCVA of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye - BCVA of 20 letters read or greater (Snellen equivalent of 20/400 or better) in the fellow eye - Clear ocular media for adequate fundus imaging in the study eye - HbA1c = 12%, as assessed by the central laboratory - Moderately severe to very severe NPDR as per ETDRS Severity Scale (Levels 47B-53E), based on 7 standard field colour fundus photograph, as assessed by the central reading centre (CRC) - No evidence of total PVD in the study eye, based on both B-scan ultrasound and SD-OCT, as assessed by the B-scan expert reader and the CRC, respectively - Written informed consent obtained from the subject prior to screening procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR (e.g. exudative AMD, retinal vein occlusion [branch or central vein], uveitis, angioid streaks, histoplasmosis, toxoplasmosis, rhegmatogenous retinal detachment, retinal tear, fibrovascular proliferation, lattice degeneration, macular hole, ocular tumours) - Clinically significant centre-involving DME in the study eye, based on SD-OCT, as assessed by the CRC - Clinically significant CME in the study eye, based on SD-OCT, as assessed by the CRC - Significant ocular trauma in the study eye within 6 months prior to screening (including corneo scleral laceration, lens subluxation, cryo-retinopexy) - Corneal, lenticular, or ocular media abnormalities in the study eye that preclude observation with the slit lamp or accurate readings with a tonometer - Presence of epiretinal membrane in the study eye, based on SD-OCT, as assessed by the CRC - Presence of foveal ischemia, macular vascularisation or peripheral non-perfusion in the study eye, based on fluorescein angiograph, as assessed by the CRC - 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 (e.g. blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis) - Open angle glaucoma or uncontrolled glaucoma in the study eye (uncontrolled glaucoma is defined as intraocular pressure [IOP] = 26mmHg despite treatment with anti-glaucoma medication) - More than 8D high myopia in the study eye (axial length of > 26.0mm on A-scan ultrasound) - Aphakic study eye - Previous treatments / procedures in the stydy eye as follows: vitrectomy, PRP and Steroid implants [any time] // Intraocular surgery and Intravitreal and peri-ocular steroids [4 months] // Focal / grid laser photocoagulation and Intravitreal anti-VEGF [3 months] // Topical ocular steroids [1 month] [excluded period period to randomisation] - Uncontrolled hypertension in the opinion of the Investigator (e.g. systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg for at least 30 days prior to screening despite antihypertensive treatment, or any finding in the Investigator’s opinion suggesting hypertensive retinopathy) - Pseudoexfoliation, Marfan’s syndrome, phacodonesis or any other finding in the Investigator’s opinion suggesting lens / zonular instability - Current use of or possible need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol - Known hypersensitivity to ocriplasmin, its excipients or any of the medications that will be used for study procedures (e.g. fluorescein, antibiotics, anaesthetic eye drops, eye drops for pupil dilation) - Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception (where 1 method is barrier at the minimum) - Previous ocriplasmin injection in the study eye - History and / or current evidence of a systemic medical condition or any other reason that may, in the Investigator’s opinion, preclude adherence to the scheduled study visits / assessments and safe participation in the study - Concurrent participation in anothe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderately severe to very severe NPDR, to induce total PVD in order to reduce the risk of disease progression to PDR;Secondary Objective: Not applicable;Primary end point(s): Total PVD by the Month 3 visit, confirmed on both B-scan ultrasound and SD-OCT (6mm), as assessed by the masked B-scan expert reader and the masked CRC, respectively ;Timepoint(s) of evaluation of this end point: Month 3 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Principal safety endpoints: - Ocular TEAEs in the study eye Safety will be further assessed through reported TEAEs, full ophthalmic examination, BCVA assessment, assessment of colour vision (subset), SD-OCT, ffERG (subset) and assessment of immunogenicity;Timepoint(s) of evaluation of this end point: From the time of providing consent until the end of the study. | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Development
ThromboGenics NV
Outcome results
None listed