Ranibizumab Versus Aflibercept for CRVO in Young Patients.

NCT05282420 | Unknown Phase 4 FDA Drug

• 1 other identifier: SVU\MED\Oph026\4\21\12\284
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Non-Ischemic Central Retinal Vein Occlusion With Macular Edema

Keywords

non ischemic CRVO; Macular edema; Ranibizumab; Aflibercept

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity BCVA

  change BCVA after injection

  at 12 months post-injection

Secondary Outcomes (1)

• reduction of macular edema

  at 12 months post-injection

Study Arms (2)

Ranibizumab group

ACTIVE COMPARATOR

Ranibizumab injection monthly for 3 successive months

Procedure: intravitreal injection of Ranibizumab; Drug: Ranibizumab

Aflibercept group

ACTIVE COMPARATOR

Aflibercept injection monthly for 3 successive months

Procedure: intravitreal injection of Aflipercept; Drug: Aflibercept

Interventions

intravitreal injection of Ranibizumab PROCEDURE

intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)

Ranibizumab group

intravitreal injection of Aflipercept PROCEDURE

intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)

Aflibercept group

Ranibizumab DRUG

Ranibizumab

Ranibizumab group

Aflibercept DRUG

Aflipercept

Aflibercept group

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients younger than 50 years with macular edema due to non-ischemic CRVO

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Ahmed Ali Ahmed Amer

Qina, Qena Governorate, 83523, Egypt

RECRUITING

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab; aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 16, 2022
• Study Start: February 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 31, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)