NCT04812977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 3, 2022

Completed
Last Updated

October 3, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

March 20, 2021

Results QC Date

May 30, 2021

Last Update Submit

April 3, 2022

Conditions

Central Retinal Vein Occlusion With Macular Edema

Keywords

central retinal vein occlusionmacular edemaintravitreal bevacizumab

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Change in visual acuity

    Baseline and 6 months

Secondary Outcomes (1)

  • Central Foveal Thickness

    Baseline and 6 months

Study Arms (2)

Group A

EXPERIMENTAL

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.

Drug: Group A

Group B

ACTIVE COMPARATOR

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

Drug: Group A

Interventions

Group ADRUG

Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)

Group AGroup B

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 26107597BACKGROUND

  • 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.

    PMID: 21305727BACKGROUND

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Results Point of Contact

Title
Yousaf Jamal Mahsood
Organization
Hayatabad Medical Complex, Peshawar
yousaf82@hotmail.com
091921714047

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 24, 2021

Study Start

June 10, 2018

Primary Completion

December 10, 2018

Study Completion

December 10, 2018

Last Updated

October 3, 2022

Results First Posted

October 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)