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

Study 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

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)

Conditions
-----------------
Ophthalmopathy

Intervention / Treatment
-----------------
* Drug: Ranibizumab
* Drug: Ranibizumab
* Drug: triamcinolone acetate


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab<br>intravetreal injection of Ranibizumab alone for treatment of patients with macular oedema after CRVO once per month and follow up | Drug: Ranibizumab<br>* Intravitreal<br>|
| Active Comparator: Ranibizumab and triamcinolone acetate<br>intravetreal injection of Ranibizumab and triamcinolone acetate for treatment of patients with macular oedema after CRVO once per month and follow up | Drug: Ranibizumab<br>* Intravitreal<br>Drug: triamcinolone acetate<br>* intravitreal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |