Ranibizumab Versus Aflibercept for CRVO in Young Patients.

Phase 4

• Conditions: Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
• Interventions: Procedure: intravitreal injection of Ranibizumab; Procedure: intravitreal injection of Aflipercept; Drug: Ranibizumab; Drug: Aflibercept

• Registration Number: NCT05282420
• Lead Sponsor: South Valley University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab group	intravitreal injection of Ranibizumab	Ranibizumab injection monthly for 3 successive months
Aflibercept group	intravitreal injection of Aflipercept	Aflibercept injection monthly for 3 successive months
Ranibizumab group	Ranibizumab	Ranibizumab injection monthly for 3 successive months
Aflibercept group	Aflibercept	Aflibercept injection monthly for 3 successive months

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity BCVA	at 12 months post-injection	change BCVA after injection

Secondary Outcome Measures

Name	Time	Method
reduction of macular edema	at 12 months post-injection	change in central subfield macular thickness CST on OCT

Trial Locations

Locations (1)

Ahmed Ali Ahmed Amer; 🇪🇬 Qinā, Qena, Egypt