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

Retinal Vein Occlusion With Macular Edema Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03353324
• Other study ID #: 9696
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 1, 2017
• Est. completion date: September 2018

Study information

• Verified date: May 2017
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Alireza Ramezani, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: September 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion
• Retinal Vein Occlusion With Macular Edema

Intervention

Drug:
• intravitreal injection of bevacizumab
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.

Radiation:
• intravitreal injection of bevacizumab+ targeted laser
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Snellen chart	Every month
Secondary	macular thickness	OCT	every month