Ranibizumab Versus Aflibercept for CRVO in Young Patients.

Study Overview
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Brief Summary
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this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old

Detailed Description
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This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study. Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\0.1ml. the second group will receive intravitreal injection of 2.0 mg\0.1 ml Aflibercept. All patients will be followed up for 12 months.

Official Title
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Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.

Conditions
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Non-Ischemic Central Retinal Vein Occlusion With Macular Edema

Intervention / Treatment
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* Procedure: intravitreal injection of Ranibizumab
* Procedure: intravitreal injection of Aflipercept
* Drug: Ranibizumab
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients younger than 50 years with macular edema due to non-ischemic CRVO Exclusion Criteria: Other conditions that might affect the macula as diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy, patients with ischemic type CRVO and patients who had recent intraocular surgery. patients who had previous intravitreal injections, ophthalmic laser surgeries. patients with dense cataracts whom fundus was difficult to scan. Patients who were lost to follow up visits were also excluded

Ages Eligible for Study
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Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months. Patients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ranibizumab group<br>Ranibizumab injection monthly for 3 successive months | Procedure: intravitreal injection of Ranibizumab<br>* intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)<br>Drug: Ranibizumab<br>* Ranibizumab<br>|
| Active Comparator: Aflibercept group<br>Aflibercept injection monthly for 3 successive months | Procedure: intravitreal injection of Aflipercept<br>* intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)<br>Drug: Aflibercept<br>* Aflipercept<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity BCVA | change BCVA after injection | at 12 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of macular edema | change in central subfield macular thickness CST on OCT | at 12 months post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept