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

October 20, 2020 updated by: He Eye Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • He Eye Specialist Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Qiqi Zhong, M.D.
        • Sub-Investigator:
          • Lanting Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRVO: Bevacizumab and intravitreal Dexamethasone
Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone.
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.
Other Names:
  • Avastin®
  • Ozurdex®
Active Comparator: BRVO: Bevacizumab
Participants with BRVO will receive Bevacizumab only.
Drug: Bevacizumab Ophthalmic
Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
Other Names:
  • Avastin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in monocular BCVA in the treatment eye
Time Frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Mean change in binocular BCVA
Time Frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in central subfield retinal thickness
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Change in Humphrey 10-2 visual field in the treatment eye
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Number of Bevacizumab. Treatments
Time Frame: Day 1 through Month 6
Number of injections provided to the patients during the 6 month period.
Day 1 through Month 6
Mean change in NEI VFQ25
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Scores from NEI VFQ25 questionnaire is assessed and compared.
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Scores from EQ-5D 5L questionnaire is assessed and compared.
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Scores from VisQoL questionnaire is assessed and compared.
Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Mean change in ocular surface and tear-film
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Mean change in vessel density
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
Side effects
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.
People meeting driving standards
Time Frame: Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Wei He, He Eye Specialist Hospital, Shenyang.
  • Principal Investigator: Jun Li, He Eye Specialist Hospital, Shenyang.
  • Study Director: Emmanuel E Pazo, He Eye Specialist Hospital, Shenyang.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 31, 2020

Primary Completion (Anticipated)

March 2, 2021

Study Completion (Anticipated)

September 17, 2021

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-260620

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Branch Retinal Vein Occlusion

Clinical Trials on Bevacizumab Ophthalmic and Intravitreal Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe