Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Primary Purpose
Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
intravitreal injection of bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Vitreous Hemorrhage focused on measuring bevacizumab,, proliferative diabetic retinopathy,, vitreous hemorrhage,
Eligibility Criteria
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.
Sites / Locations
- Srinagarind Hospital, Khon Kaen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intravitreal bevacizumab injection
Arm Description
intravitreal injection of bevacizumab 1.25 mg
Outcomes
Primary Outcome Measures
The percentage of eyes that vitreous hemorrhage has been completely resolved
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 Outcome Measures
The change in best corrected visual acuity (BCVA) from baseline
The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01724385
Brief Title
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Official Title
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
Keywords
bevacizumab,, proliferative diabetic retinopathy,, vitreous hemorrhage,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intravitreal bevacizumab injection
Arm Type
Experimental
Arm Description
intravitreal injection of bevacizumab 1.25 mg
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
intravitreal injection of bevacizumab
Primary Outcome Measure Information:
Title
The percentage of eyes that vitreous hemorrhage has been completely resolved
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The change in best corrected visual acuity (BCVA) from baseline
Description
The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Numbers of injection
Description
Numbers of intravitreous bevacizumab injection in a 12-month period
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, M.D.
Organizational Affiliation
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
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