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

Branch Retinal Vein Occlusion Clinical Trial

Official title:

Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04601688
• Other study ID #: ME-260620
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: September 17, 2021

Study information

• Verified date: October 2020
• Source: He Eye Hospital
• Contact: Jun Li, M.D., Ph.D.
• Phone: 0086-15104083505
• Email: robin_lijun[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 17, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Bevacizumab Ophthalmic and Intravitreal Dexamethasone
Pro re nata patients with BRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
• Bevacizumab Ophthalmic
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.

Locations

Country	Name	City	State
China	He Eye Specialist Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in monocular BCVA in the treatment eye	Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.	Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Primary	Mean change in binocular BCVA	Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.	Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in central subfield retinal thickness	Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT) is assessed and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Change in Humphrey 10-2 visual field in the treatment eye	Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Number of Bevacizumab. Treatments	Number of injections provided to the patients during the 6 month period.	Day 1 through Month 6
Secondary	Mean change in NEI VFQ25	Scores from NEI VFQ25 questionnaire is assessed and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in EQ-5D 5L	Scores from EQ-5D 5L questionnaire is assessed and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in VisQoL scores	Scores from VisQoL questionnaire is assessed and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in wavefront aberrations	Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in ocular surface and tear-film	Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Mean change in vessel density	Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	Side effects	Side effects are measured by a review of the participant's medical and ophthalmic history.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Secondary	People meeting driving standards	Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared.	Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.