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Clinical Trials/NCT05282420
NCT05282420
Unknown
Phase 4

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

South Valley University1 site in 1 country40 target enrollmentFebruary 1, 2021

Overview

Phase
Phase 4
Intervention
Aflibercept
Conditions
Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
Sponsor
South Valley University
Enrollment
40
Locations
1
Primary Endpoint
Best corrected visual acuity BCVA
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
May 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Ali Ahmed Amer

Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt

South Valley University

Eligibility Criteria

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

Arms & Interventions

Aflibercept group

Aflibercept injection monthly for 3 successive months

Intervention: Aflibercept

Ranibizumab group

Ranibizumab injection monthly for 3 successive months

Intervention: intravitreal injection of Ranibizumab

Ranibizumab group

Ranibizumab injection monthly for 3 successive months

Intervention: Ranibizumab

Aflibercept group

Aflibercept injection monthly for 3 successive months

Intervention: intravitreal injection of Aflipercept

Outcomes

Primary Outcomes

Best corrected visual acuity BCVA

Time Frame: at 12 months post-injection

change BCVA after injection

Secondary Outcomes

  • reduction of macular edema(at 12 months post-injection)

Study Sites (1)

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