Ranibizumab Versus Aflibercept for CRVO in Young Patients.

South Valley University

Status and phase: Unknown; Phase 4

Conditions: Non-Ischemic Central Retinal Vein Occlusion With Macular Edema

Treatments: Drug: Ranibizumab; Procedure: intravitreal injection of Ranibizumab; Procedure: intravitreal injection of Aflipercept; Drug: Aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT05282420

SVU\MED\Oph026\4\21\12\284

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Ranibizumab group

Active Comparator group

Description:

Ranibizumab injection monthly for 3 successive months

Treatment:

Drug: Ranibizumab

Procedure: intravitreal injection of Ranibizumab

Aflibercept group

Active Comparator group

Description:

Aflibercept injection monthly for 3 successive months

Treatment:

Drug: Aflibercept

Procedure: intravitreal injection of Aflipercept