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

NCT03353324 | Unknown Phase 2

• 1 other identifier: 9696
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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,

Conditions

Retinal Vein Occlusion With Macular Edema

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Snellen chart

  Every month

Secondary Outcomes (1)

• macular thickness

  every month

Study Arms (2)

intravitreal injection of bevacizumab

ACTIVE COMPARATOR

Drug: intravitreal injection of bevacizumab

intravitreal injection of bevacizumab+ targeted laser

ACTIVE COMPARATOR

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

Radiation: intravitreal injection of bevacizumab+ targeted laser

Interventions

intravitreal injection of bevacizumab DRUG

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.

intravitreal injection of bevacizumab

intravitreal injection of bevacizumab+ targeted laser RADIATION

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

intravitreal injection of bevacizumab+ targeted laser

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

Central Study Contacts

Alireza Ramezani, MD

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: November 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 31, 2018

Record last verified: 2017-05

Locations

IR (1)