Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.

He Eye Hospital

Status: Unknown

Conditions: Branch Retinal Vein Occlusion

Treatments: Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone; Drug: Bevacizumab Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT04601688

ME-260620

Details and patient eligibility

About

The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.

Full description

The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent must be obtained before any study assessment is performed
2. Diagnosis of visual impairment exclusively due to ME secondary to BRVO
3. BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart.
4. Central foveal thickness (CFT) ≥ 300 µm
5. Naive Eyes

Exclusion criteria

1. Pregnant or nursing (lactating) women
2. Stroke or myocardial infarction less than 3 months before Screening
3. Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline.
4. Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
5. Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
6. Neovascularization of the iris or neovascular glaucoma in the study eye
7. Use of any systemic or ocular antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
8. Panretinal laser photocoagulation performed, anticipated or scheduled in the study eye
9. Focal or grid laser photocoagulation in the study eye
10. Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye
11. Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

BRVO: Bevacizumab and intravitreal Dexamethasone

Experimental group

Description:

Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.

Treatment:

Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone

BRVO: Bevacizumab

Active Comparator group

Description:

Participants with BRVO will receive Bevacizumab only.

Treatment:

Drug: Bevacizumab Ophthalmic