Prevention of rebleeding with Ozurdex implants after surgery for vitreous bleedning in diabetic patients
- Conditions
- Proliferative diabetic retinopathyMedDRA version: 14.0Level: LLTClassification code 10036857Term: Proliferative diabetic retinopathySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-003297-81-SE
- Lead Sponsor
- St Eriks Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
•Previous PPV
•Vitreous hemorrhage of non-PDRP origin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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