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

NCT ID: NCT03353324

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-09-30

Brief Summary

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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,

Detailed Description

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Conditions

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Retinal Vein Occlusion With Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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intravitreal injection of bevacizumab

Group Type ACTIVE_COMPARATOR

intravitreal injection of bevacizumab

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

intravitreal injection of bevacizumab+ targeted laser

Intervention Type 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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type RADIATION

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Alireza Ramezani, MD

Role: CONTACT

Phone: 009822591616

Email: [email protected]

Facility Contacts

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alireaza ramezani, MD

Role: primary

Other Identifiers

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9696

Identifier Type: -

Identifier Source: org_study_id