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

Central Retinal Vein Occlusion With Macular Edema Clinical Trial

— CRVO  

Official title:

Comparison of Intravitreal Bevacizumab and Triamcinolone Acetonide With Intravitreal Bevacizumab Alone in Macular Edema Secondary to Central Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812977
• Other study ID #: 094/HEC/PICO/18
• Status: Completed
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: December 10, 2018

Study information

• Verified date: April 2022
• Source: Hayatabad Medical Complex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion With Macular Edema
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Group A
Combination of intravitreal triamcinolone acetonide (Kenacort-A?) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)

Locations

Country	Name	City	State
Pakistan	Hayatabad Medical Complex	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Hayatabad Medical Complex

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Change in visual acuity	Baseline and 6 months
Secondary	Central Foveal Thickness	change in central foveal thickness	Baseline and 6 months