Back to resultsComparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion (bevacizumab)
Primary Purpose
Retinal Vein Occlusion With Macular Edema
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
intravitreal injection of bevacizumab
intravitreal injection of bevacizumab+ targeted laser
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Vein Occlusion With Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Center-involved macular edema secondary to RVO on clinical exam
- Symptoms less than 3 months
- BCVA= 20/40 or worse
- Mean center point thickness >250 μm
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
One eye per participant is enrolled in the trial
Exclusion Criteria:
- Macular edema due to a cause other than CRVO
- An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
- Substantial cataract estimated to have reduced visual acuity by >3 lines
- Prior treatment with intravitreal or peribulbar steroid injection
- History of macular photocoagulation or PRP
- Prior pars plana vitrectomy
- Hx of Intraocular surgery (including cataract extraction)
- uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
- vitreomacular traction or epiretinal membrane *uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intravitreal injection of bevacizumab
intravitreal injection of bevacizumab+ targeted laser
Arm Description
Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas
Outcomes
Primary Outcome Measures
Visual acuity
Snellen chart
Secondary Outcome Measures
macular thickness
OCT
Full Information
NCT ID
NCT03353324
First Posted
November 21, 2017
Last Updated
May 29, 2018
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03353324
Brief Title
Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
Acronym
bevacizumab
Official Title
Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with new onset retinal vein occlusion in less than 3 month whom has visual acuity less than 20/40 and central macular thickness more than 250micrometer and non perfused areas of retina more than 10 DD are included in over study and devided into 2 groups randomizely, Group A under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeated and follow up in this manner is continued until 9 months.
Group B is as the same of group A but patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion With Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravitreal injection of bevacizumab
Arm Type
Active Comparator
Arm Title
intravitreal injection of bevacizumab+ targeted laser
Arm Type
Active Comparator
Arm Description
Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of bevacizumab
Intervention Description
under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeatet and follow up in this manner is continued until 9 months.
Intervention Type
Radiation
Intervention Name(s)
intravitreal injection of bevacizumab+ targeted laser
Intervention Description
patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared
Primary Outcome Measure Information:
Title
Visual acuity
Description
Snellen chart
Time Frame
Every month
Secondary Outcome Measure Information:
Title
macular thickness
Description
OCT
Time Frame
every month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Center-involved macular edema secondary to RVO on clinical exam
Symptoms less than 3 months
BCVA= 20/40 or worse
Mean center point thickness >250 μm
Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
One eye per participant is enrolled in the trial
Exclusion Criteria:
Macular edema due to a cause other than CRVO
An ocular condition such that visual acuity would not improve from resolution of the edema (eg, foveal atrophy)
Substantial cataract estimated to have reduced visual acuity by >3 lines
Prior treatment with intravitreal or peribulbar steroid injection
History of macular photocoagulation or PRP
Prior pars plana vitrectomy
Hx of Intraocular surgery (including cataract extraction)
uveitis, NVG, exudative AMD, diabetic retinopathy, any malignancy, optic neuropathy, amblyopia
vitreomacular traction or epiretinal membrane *uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Ramezani, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alireaza ramezani, MD
Phone
009822591616
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Therapeutic Effects Between Intravitreal Injection of Bevacizumab With Intravitreal Injection of Bevacizumab and Targeted Laser Photocoagulation of Non Perfused Areas of Retina in Patients With Acute Retinal Vein Occlusion
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