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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

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

NCT ID

NCT04812977

First Posted

March 20, 2021

Last Updated

April 3, 2022

Sponsor

Hayatabad Medical Complex

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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

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

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

background

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

background

Learn more about this trial

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

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