Ranibizumab Versus Aflibercept for CRVO in Young Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-05-31

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

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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.

Conditions

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Non-Ischemic Central Retinal Vein Occlusion With Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ranibizumab group

Ranibizumab injection monthly for 3 successive months

Group Type ACTIVE_COMPARATOR

intravitreal injection of Ranibizumab

Intervention Type PROCEDURE

intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)

Ranibizumab

Intervention Type DRUG

Ranibizumab

Aflibercept group

Aflibercept injection monthly for 3 successive months

Group Type ACTIVE_COMPARATOR

intravitreal injection of Aflipercept

Intervention Type PROCEDURE

intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)

Aflibercept

Intervention Type DRUG

Aflipercept

Interventions

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intravitreal injection of Ranibizumab

intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)

Intervention Type PROCEDURE

intravitreal injection of Aflipercept

intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)

Intervention Type PROCEDURE

Ranibizumab

Intervention Type DRUG

Aflibercept

Aflipercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients younger than 50 years with macular edema due to non-ischemic CRVO

Exclusion Criteria

1. diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
2. patients with ischemic type CRVO and patients who had recent intraocular surgery.
3. patients who had previous intravitreal injections, ophthalmic laser surgeries.
4. patients with dense cataracts whom fundus was difficult to scan.
5. Patients who were lost to follow up visits were also excluded

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No