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 (bevacizumab)

S

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Retinal Vein Occlusion With Macular Edema

Treatments

Radiation: intravitreal injection of bevacizumab+ targeted laser
Drug: intravitreal injection of bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03353324
9696

Details and patient eligibility

About

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,

Enrollment

74 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 2 patient groups

intravitreal injection of bevacizumab
Active Comparator group
Treatment:
Drug: intravitreal injection of bevacizumab
intravitreal injection of bevacizumab+ targeted laser
Active Comparator group
Description:
Intervention intravitreal bevacizumab injection + targeted laser photocoagulation of retinal non perfused areas
Treatment:
Radiation: intravitreal injection of bevacizumab+ targeted laser

Trial contacts and locations

0

Loading...

Central trial contact

Alireza Ramezani, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems