Proliferative Diabetic Retinopathy, Vitreous Hemorrhage
Conditions
Keywords
bevacizumab,, proliferative diabetic retinopathy,, vitreous hemorrhage,
Brief summary
To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).
Detailed description
The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.
Interventions
intravitreal injection of bevacizumab
Sponsors
Khon Kaen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients with diabetes mellitus * proliferative diabetic retinopathy * prior complete panretinal photocoagulation * presented with new dense vitreous hemorrhage
Exclusion criteria
* one-eyed patient * previous intraocular surgery * severe lens opacity precluding fundus examination * advance glaucoma * history of thromboembolic events such as myocardial infarction and cerebrovascular accident * uncontrolled systemic hypertension, systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg * known coagulation abnormalities or current use of anticoagulant medications other than aspirin * known allergies to any relevant drugs in this study * evidence of external ocular infection such as conjunctivitis and significant blepharitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of eyes that vitreous hemorrhage has been completely resolved | 12 months | The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in best corrected visual acuity (BCVA) from baseline | 12 months | The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Numbers of injection | 12 months | Numbers of intravitreous bevacizumab injection in a 12-month period |
Countries
Thailand
Outcome results
None listed