Cardiovascular Diseases, Diabetic Angiopathies, Diabetic Retinopathy, Eye Diseases, Retinal Diseases, Vascular Diseases
Conditions
Keywords
Proliferative Diabetic Retinopathy, Ranibizumab, Panretinal Photocoagulation
Brief summary
To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).
Detailed description
Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR). Objectives: Primary objective: The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS). Secondary objectives: To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments. To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments. Strategic goal: The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome
Interventions
DRUGRanibizumab
Intravitreal injection
PROCEDURELaser therapy
Laser therapy
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Naive Proliferative diabetic retinopathy eyes. * Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye * Patients with and without diabetic macular edema * Type II diabetic subjects as defined by the World Health Organization aged ≥ 18 years. * Women must be using effective contraception * Ability to provide written informed consent. * Indication of panretinal photocoagulation in both eyes
Exclusion criteria
* Vitreous hemorrhage or pre-retinal hemorrhage * Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months * Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula. * Cataract * Any intraocular surgery within 6 months before trial enrollment * Previous vitrectomy. * Any of the following underlying systemic diseases: * History or evidence of severe cardiac disease or previous thrombus-embolic event
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Evaluation | 6 Months | Changes between visual acuity from baseline to month 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Structural Macular Evaluation | 06 months | Change on retinal thickness between baseline and Month 6 |
Countries
Brazil
Outcome results
None listed