Clinical trial NCT04601688: Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
Official title: Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Branch Retinal Vein Occlusion
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in monocular BCVA in the treatment eye
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in binocular BCVA
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary outcomes:
measure: Mean change in central subfield retinal thickness
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Change in Humphrey 10-2 visual field in the treatment eye
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Number of Bevacizumab. Treatments
timeFrame: Day 1 through Month 6
measure: Mean change in NEI VFQ25
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in EQ-5D 5L
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in VisQoL scores
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in wavefront aberrations
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in ocular surface and tear-film
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in vessel density
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Side effects
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: People meeting driving standards
timeFrame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Specialist Hospital
state: Liaoning
Study officials:
affiliation: He Eye Specialist Hospital, Shenyang.
name: Wei He
role: STUDY_CHAIR
affiliation: He Eye Specialist Hospital, Shenyang.
name: Jun Li
role: PRINCIPAL_INVESTIGATOR
affiliation: He Eye Specialist Hospital, Shenyang.
name: Emmanuel E Pazo
role: STUDY_DIRECTOR
References: