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Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion (CRVO)

Primary Purpose

Central Retinal Vein Occlusion With Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A
Sponsored by
Hayatabad Medical Complex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion With Macular Edema focused on measuring central retinal vein occlusion, macular edema, intravitreal bevacizumab

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects of either gender, age 40-80 years, having macular edema secondary to CRVO, Best-corrected visual acuity (BCVA) of less than or equal to 0.3 on Log MAR chart (Snellen equivalent of 6/12), Central foveal thickness CFT greater than or equal to 250 microns on Heidelberg Spectralis Spectral Domain Optical coherence tomography (SD-OCT) and clinical diagnosis of CRVO.

Exclusion Criteria:

  • previously received laser treatment and/or intravitreal injection of any Anti-VEGF agent, having one eye, diagnosed case of glaucoma, family history of glaucoma, young patient, and anyone who has received any treatment for CRVO before presenting to us.

Sites / Locations

  • Hayatabad Medical Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months.

Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months.

Outcomes

Primary Outcome Measures

Visual Acuity
Change in visual acuity

Secondary Outcome Measures

Central Foveal Thickness
change in central foveal thickness

Full Information

First Posted
March 20, 2021
Last Updated
April 3, 2022
Sponsor
Hayatabad Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT04812977
Brief Title
Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion
Acronym
CRVO
Official Title
Comparison of Intravitreal Bevacizumab and Triamcinolone Acetonide With Intravitreal Bevacizumab Alone in Macular Edema Secondary to Central Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hayatabad Medical Complex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
To compare the effect of intravitreal-Bevacizumab and Triamcinolone with intravitreal-Bevacizumab alone on visual acuity and central foveal thickness in patients with macular edema secondary to central retinal vein occlusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion With Macular Edema
Keywords
central retinal vein occlusion, macular edema, intravitreal bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months.
Intervention Type
Drug
Intervention Name(s)
Group A
Intervention Description
Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Change in visual acuity
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Central Foveal Thickness
Description
change in central foveal thickness
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects of either gender, age 40-80 years, having macular edema secondary to CRVO, Best-corrected visual acuity (BCVA) of less than or equal to 0.3 on Log MAR chart (Snellen equivalent of 6/12), Central foveal thickness CFT greater than or equal to 250 microns on Heidelberg Spectralis Spectral Domain Optical coherence tomography (SD-OCT) and clinical diagnosis of CRVO. Exclusion Criteria: previously received laser treatment and/or intravitreal injection of any Anti-VEGF agent, having one eye, diagnosed case of glaucoma, family history of glaucoma, young patient, and anyone who has received any treatment for CRVO before presenting to us.
Facility Information:
Facility Name
Hayatabad Medical Complex
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26107597
Citation
Yoshizawa C, Saito W, Kase M, Ishida S. Clinical Features of Central Retinal Vein Occlusion With Inflammatory Etiology. Asia Pac J Ophthalmol (Phila). 2012 Sep-Oct;1(5):270-6. doi: 10.1097/APO.0b013e318266de04.
Results Reference
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PubMed Identifier
21305727
Citation
Lazic R, Boras I, Vlasic M, Gabric N, Tomic Z. Anti-VEGF in treatment of central retinal vein occlusion. Coll Antropol. 2010 Apr;34 Suppl 2:69-72.
Results Reference
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Comparison of Intravitreal Anti-VEGF Versus Combination Therapy in Central Retinal Vein Occlusion

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