Diabetic Retinopathy
Conditions
Keywords
Severe proliferative diabetic retinopathy
Brief summary
This study investigates the hypothesis that ranibizumab injection given into the eye is a safe, efficacious and helping treatment option applied before surgical intervention of the proliferative diabetic retinal eye disorder.
Detailed description
This is a randomized, double blinded , controlled, two-center study assessing the feasibility, efficacy and safety of intravitreal ranibizumab injection applied as a preoperative adjunct treatment before vitrectomy surgery in severe proliferative diabetic retinopathy (PDR). Comparator arm consists of patients receiving standard vitrectomy alone with sham intravitreal injection preoperatively.
Interventions
DRUGranibizumab and vitrectomy
ranibizumab 10mg/ml intravitreal injection, 0,05 ml
PROCEDUREvitrectomy without preoperative ranibizumab
sham intravitreal injection before vitrectomy surgery
Sponsors
Semmelweis University
Attila Vajas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female 18 or older who have signed an informed consent * Type I or II diabetes mellitus and severe proliferative retinopathy with tractional retinal detachment, tractional-rhegmatogenous retinal detachment, tractional detachment complicated with vitreous haemorrhage or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation * study eye BCVA must have at least light perception and must not exceed 70 letters using ETDRS at testing distance 4 meters * study eye vision decrease must be resulted from severe PDR
Exclusion criteria
* Active ocular inflammation or infection * History of uveitis * Uncontrolled glaucoma * High myopia * Any concurrent intraocular condition in the study eye that in the opinion of the investigator could confound the study results * Former treatment with anti-angiogenic drugs within 30 days preceding Day 1 in the study eye * History of vitrectomy within 60 days preceding Day 1 in the study eye * History of intraocular surgery within 30 days preceding Day 1 in the study eye * Untreated diabetes mellitus * Severe hypertension (systolic pressure higher than 160mmHg) * Current use of systemic medications known to be toxic to the retina * History of thromboembolic events (incl MI and stroke) within 5 years * Major surgery within previous 3 months or planned within the next 28 days * Known coagulation abnormalities or current use of anticoagulative medications other than aspirins * Known hypersensitivity to ranibizumab or any component of it * Women of childbearing potential unless 2 methods of birth control applied * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of preoperative intravitreal ranibizumab | OP day | Efficacy, measured by surgical time, number of intraoperative bleedings, intraoperative retinal breaks,required endodiathermy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BCVA. | 6 months | — |
| Effect in anatomical changes. | 3 ±1 days after injection | — |
| Safety. | Over 6 months. | — |
| Retinal circulation integrity. | Month 1, 3, 6. | Evaluating the circulation of original retinal vessels, evaluating the size of proliferative vessels (size of leaking areas and number of leaking points measured by Fluorescein angiography ) |
Countries
Hungary
Outcome results
None listed