Proliferative Diabetic Retinopathy
Conditions
Keywords
diabetic retinopathy, ranibizumab, new vessels, intravitreal injection, Persistent retina new vessels
Brief summary
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.
Interventions
0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography
Sponsors
Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA)
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior; * logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.
Exclusion criteria
* history of vitrectomy in the study eye; * history of thromboembolic event (including myocardial infarction or cerebral vascular accident); * major surgery within the prior 6 months or planned within the next 28 days; * uncontrolled hypertension; * known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total area of fluorescein leakage from active new vessels | baseline, weeks 1,6,12,24,36,48 |
| Best corrected Visual Acuity (BCVA) | Baseline, weeks 1,6,12,24,36,48 |
| central macular thickness | baseline, weeks 1,6,12,24,36,48 |
Outcome results
None listed