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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)

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ClinicalTrials.gov Identifier: NCT03353324
Recruitment Status : Unknown
Verified May 2017 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 27, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, 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,


Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion With Macular Edema Drug: intravitreal injection of bevacizumab Radiation: intravitreal injection of bevacizumab+ targeted laser Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: intravitreal injection of bevacizumab 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.

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





Primary Outcome Measures :
  1. Visual acuity [ Time Frame: Every month ]
    Snellen chart


Secondary Outcome Measures :
  1. macular thickness [ Time Frame: every month ]
    OCT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353324


Contacts
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Contact: Alireza Ramezani, MD 009822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: alireaza ramezani, MD    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Responsible Party: Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03353324    
Other Study ID Numbers: 9696
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors