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

NCT04601688 | Unknown DMC

• 1 other identifier: ME-260620
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Branch Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (11)

• Mean change in central subfield retinal thickness

  Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.

• Change in Humphrey 10-2 visual field in the treatment eye

  Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.

• Number of Bevacizumab. Treatments

  Day 1 through Month 6

• Mean change in NEI VFQ25

  Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.

• Mean change in EQ-5D 5L

  Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months.

Study Arms (2)

BRVO: Bevacizumab and intravitreal Dexamethasone

EXPERIMENTAL

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

Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone

BRVO: Bevacizumab

ACTIVE COMPARATOR

Participants with BRVO will receive Bevacizumab only.

Drug: Bevacizumab Ophthalmic

Interventions

Bevacizumab Ophthalmic and Intravitreal Dexamethasone DRUG

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®

BRVO: Bevacizumab and intravitreal Dexamethasone

Bevacizumab Ophthalmic DRUG

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®

BRVO: Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He Eye Specialist Hospital

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Bevacizumab; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Wei He

  He Eye Specialist Hospital, Shenyang.

  STUDY CHAIR

• Jun Li

  He Eye Specialist Hospital, Shenyang.

  PRINCIPAL INVESTIGATOR

• Emmanuel E Pazo

  He Eye Specialist Hospital, Shenyang.

  STUDY DIRECTOR

Central Study Contacts

Jun Li, M.D., Ph.D.

CONTACT

0086-15104083505; robin_lijun@sina.com

Emmanuel E Pazo

CONTACT

0086-18612782131; ericpazo@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: October 31, 2020
• Primary Completion: March 2, 2021
• Study Completion: September 17, 2021
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

CN (1)