Ranibizumab Versus Aflibercept for CRVO in Young Patients.

• Sponsor: Qena Faculty of medicine, South Valley University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05282420
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.9
• Patients Per Site Per Month: 2.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non-Ischemic Central Retinal Vein Occlusion With Macular Edema	Procedure: intravitreal injection of Ranibizumab; Procedure: intravitreal injection of Aflipercept; Drug: Ranibizumab; Drug: Aflibercept	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 drugsPatients 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: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Ranibizumab Versus Aflibercept for Macular Edema Secondary to Non-ischemic Central Retinal Vein Occlusion in Young Adult Patients.
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Best corrected visual acuity BCVA [at 12 months post-injection]

   change BCVA after injection

Secondary Outcome Measures

1. reduction of macular edema [at 12 months post-injection]

   change in central subfield macular thickness CST on OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Ali Ahmed Amer	Qinā	Qena	Egypt	83523

Sponsors and Collaborators

• Qena Faculty of medicine, South Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Ali Ahmed Amer, Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt, Qena Faculty of medicine, South Valley University
• ClinicalTrials.gov Identifier: NCT05282420
• Other Study ID Numbers: SVU\MED\Oph026\4\21\12\284
• First Posted: Mar 16, 2022
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Ahmed Ali Ahmed Amer, Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt, Qena Faculty of medicine, South Valley University: non ischemic CRVO; Macular edema; Ranibizumab; Aflibercept
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Ranibizumab; Aflibercept

Study Results

No Results Posted as of Mar 16, 2022