An interventional study of Bevacizumab Ophthalmic and Intravitreal Dexamethasone and Bevacizumab Ophthalmic in Branch Retinal Vein Occlusion, sponsored by He Eye Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-26.
Sponsored by He Eye Hospital · Not applicable, Interventional, and Treatment
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.
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.
282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.
This study's planned enrollment of 100 is above the median of 49 across 211 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →He Eye Hospital is the lead sponsor of 31 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone
Participants with BRVO will receive Bevacizumab only.
Drug: Bevacizumab Ophthalmic
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.
Also known as: Avastin®, Ozurdex®
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
Also known as: Avastin®
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.
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared.
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Number of Bevacizumab. Treatments
Number of injections provided to the patients during the 6 month period.
Time frame: Day 1 through Month 6
Mean change in NEI VFQ25
Scores from NEI VFQ25 questionnaire is assessed and compared.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Scores from EQ-5D 5L questionnaire is assessed and compared.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Scores from VisQoL questionnaire is assessed and compared.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared.
Time frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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He Eye Hospital