Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)

Ophthalmopathy Clinical Trial

Official title:

Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460001
• Other study ID #: WAMohamed
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 16, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2019
• Source: Assiut University
• Contact: Wael Ismael
• Phone: 01006322380
• Email: wael.ali.ismael[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.

• A BCVA approximate Snellen equivalents, 20/40.

Exclusion Criteria:

• Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.

• Pan-retinal laser photocoagulation 3 months or less before baseline,

• Topical ocular or systemic corticosteroids administered for 30 consecutive days.

• Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),

• Use of intraocular corticosteroid implants,

• Uncontrolled glaucoma (intraocular pressure [IOP] 30 mmHg with medication) at the time of screening or baseline,

• iris neovascularization or neo-vascular glaucoma.

Related Conditions & MeSH terms

• Eye Diseases
• Ophthalmopathy

Intervention

Drug:
• Ranibizumab
Intravitreal
• Ranibizumab
Intravitreal
• triamcinolone acetate
intravitreal

Locations

Country	Name	City	State
Egypt	Wael	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO	To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Best-Corrected Visual Acuity: will be assessed at every study visit by using alandolt ringes VA testing chart at an initial testing distance of 6 m.	2 year
Primary	Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO	To compare the clinical effectiveness of 0.5 mg ranibizumab and combination of ranibizumab and triamcinolone 0.3/0.5mg for the treatment of macular oedema secondary to CRVO.Study assessments will be performed at screening, baseline and at monthly visits: Optical Coherence Tomography: will be performed at every visit and the same machine will be used for assessment of the same patient throughout the study. investigator will evaluate the images according to central foveal thickness, and the retinal thickness at the foveal center point and to capture the presence or absence of qualitative parameters (i.e., intraretinal cystoid fluid and subretinal fluid).	2 year