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

Phase 2

• Conditions: Retinal Vein Occlusion With Macular Edema
• Interventions: Drug: intravitreal injection of bevacizumab; Radiation: intravitreal injection of bevacizumab+ targeted laser

• Registration Number: NCT03353324
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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,

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-11-01
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Primary Completion: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravitreal injection of bevacizumab	intravitreal injection of bevacizumab	-
intravitreal injection of bevacizumab+ targeted laser	intravitreal injection of bevacizumab+ targeted laser	Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas

Primary Outcome Measures

Name	Time	Method
Visual acuity	Every month	Snellen chart

Secondary Outcome Measures

Name	Time	Method
macular thickness	every month	OCT

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of