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

Phase 2

• Conditions: Ophthalmopathy
• Interventions: Drug: Ranibizumab; Drug: triamcinolone acetate

• Registration Number: NCT04460001
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2019-08-01
• Status Verified: 2019-11
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab and triamcinolone acetate	triamcinolone acetate	intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
Ranibizumab	Ranibizumab	intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up
Ranibizumab and triamcinolone acetate	Ranibizumab	intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up

Primary Outcome Measures

Name	Time	Method
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO	2 year	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).

Trial Locations

Locations (1)

Wael; 🇪🇬 Asyut, Egypt