Back to resultsRanibizumab Versus Aflibercept for CRVO in Young Patients.
Primary Purpose
Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
intravitreal injection of Ranibizumab
intravitreal injection of Aflipercept
Ranibizumab
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Non-Ischemic Central Retinal Vein Occlusion With Macular Edema focused on measuring non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept
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
Sites / Locations
- Ahmed Ali Ahmed AmerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ranibizumab group
Aflibercept group
Arm Description
Ranibizumab injection monthly for 3 successive months
Aflibercept injection monthly for 3 successive months
Outcomes
Primary Outcome Measures
Best corrected visual acuity BCVA
change BCVA after injection
Secondary Outcome Measures
reduction of macular edema
change in central subfield macular thickness CST on OCT
Full Information
NCT ID
NCT05282420
First Posted
March 4, 2022
Last Updated
March 15, 2022
Sponsor
Qena Faculty of medicine, South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT05282420
Brief Title
Ranibizumab Versus Aflibercept for CRVO in Young Patients.
Official Title
Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qena Faculty of medicine, South Valley University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Ischemic Central Retinal Vein Occlusion With Macular Edema
Keywords
non ischemic CRVO, Macular edema, Ranibizumab, Aflibercept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab group
Arm Type
Active Comparator
Arm Description
Ranibizumab injection monthly for 3 successive months
Arm Title
Aflibercept group
Arm Type
Active Comparator
Arm Description
Aflibercept injection monthly for 3 successive months
Intervention Type
Procedure
Intervention Name(s)
intravitreal injection of Ranibizumab
Intervention Description
intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)
Intervention Type
Procedure
Intervention Name(s)
intravitreal injection of Aflipercept
Intervention Description
intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Ranibizumab
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
Aflipercept
Primary Outcome Measure Information:
Title
Best corrected visual acuity BCVA
Description
change BCVA after injection
Time Frame
at 12 months post-injection
Secondary Outcome Measure Information:
Title
reduction of macular edema
Description
change in central subfield macular thickness CST on OCT
Time Frame
at 12 months post-injection
10. Eligibility
Sex
All
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ahmed Ali Ahmed Amer
City
Qinā
State/Province
Qena
ZIP/Postal Code
83523
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Ahmed Amer, MD
Phone
+201011827000
Email
AhmedAli.ophth@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Ranibizumab Versus Aflibercept for CRVO in Young Patients.
We'll reach out to this number within 24 hrs