Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Overview
- Phase
- Phase 2
- Intervention
- Ranibizumab
- Conditions
- Ophthalmopathy
- Sponsor
- Assiut University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
- Last Updated
- 5 years ago
Overview
Brief Summary
To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO
Investigators
Wael Ali Mohamed
Principal Investigator
Assiut University
Eligibility Criteria
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.
Arms & Interventions
Ranibizumab
intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up
Intervention: Ranibizumab
Ranibizumab and triamcinolone acetate
intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
Intervention: Ranibizumab
Ranibizumab and triamcinolone acetate
intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up
Intervention: triamcinolone acetate
Outcomes
Primary Outcomes
Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
Time Frame: 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).