Proliferative diabetic retinopathy MedDRA version: 14.0 Level: LLT Classification code 10036857 Term: Proliferative diabetic retinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Ozurdex
Product Name: Ozurdex
Pharmaceutical Form: Prolonged-release capsule
Sponsors
St Eriks Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients undergoing PPV for PDRP • Reoperation will be performed on patients with persistent or recurrent vitreous hemorrhage that have not cleared after one month Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: • Previous PPV • Vitreous hemorrhage of non-PDRP origin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP);Secondary Objective: No;Primary end point(s): The proportion of patients that, due to re-bleeding within 12 months, have a second PPV;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Sweden
Contacts
Public ContactAnders Kvanta
St Eriks Eye Hospital
Outcome results
None listed