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

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT03353324
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Retinal Vein Occlusion With Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

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+ 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

Study Details

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,

Key Dates

First listed
Nov 27, 2017
Start date
Nov 1, 2017
Status verified
May 2017
Primary completion
May 31, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: intravitreal injection of bevacizumab
  • Active Comparator: intravitreal injection of bevacizumab+ targeted laser
    Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas

Primary Outcome Measure

Visual acuity [ Time Frame: Every month ]

Central Contacts