Ranibizumab Versus Aflibercept for CRVO in Young Patients.

March 15, 2022 updated by: Ahmed Ali Ahmed Amer, Qena Faculty of medicine, South Valley University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qena
      • Qinā, Qena, Egypt, 83523
        • Recruiting
        • Ahmed Ali Ahmed Amer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qena Faculty of medicine, South Valley University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU\MED\Oph026\4\21\12\284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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