Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.

NCT04601701 | Unknown DMC

• 1 other identifier: ME-270620
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Bevacizumab (Avastin) in combination with Dexamethasone (Ozurdex) will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO) in comparison to Bevacizumab (Avastin) alone.

Conditions

Central 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.

  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.

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

Secondary Outcomes (11)

• Mean change in central subfield retinal thickness

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

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

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

• Number of Ranibizumab Treatments

  Day 1 through Month 6

• Mean change in NEI VFQ25 Questionnaire Score

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

• Mean change in VisQoL scores

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

Study Arms (2)

CRVO: Bevacizumab and intravitreal Dexamethasone.

EXPERIMENTAL

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

Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone.

CRVO: Bevacizumab

ACTIVE COMPARATOR

Participants with CRVO will receive a combination of Bevacizumab only.

Drug: Bevacizumab Ophthalmic.

Interventions

Bevacizumab Ophthalmic and Intravitreal Dexamethasone. DRUG

Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected.

Also known as: Avastin®, Ozurdex®

CRVO: Bevacizumab and intravitreal Dexamethasone.

Bevacizumab Ophthalmic. DRUG

Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, Bevacizumab will be injected.

Also known as: Avastin®

CRVO: 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 CRVO
• BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)

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 antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
• Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
• Focal or grid laser photocoagulation within 4 months before Baseline 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

RECRUITING

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, M.D., Ph.D.

  He Eye Specialist Hospital, Shenyang.

  STUDY CHAIR

• Jun Li, M.D., Ph.D.

  He Eye Specialist Hospital, Shenyang.

  PRINCIPAL INVESTIGATOR

• Emmanuel E Pazo, M.D., Ph.D.

  He Eye Specialist Hospital, Shenyang.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

0086-411-86525401; robin_lijun@sina.com

Emmanuel E Pazo, M.D., Ph.D.

CONTACT

008618612782131; 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: August 26, 2020
• First Posted: October 26, 2020
• Study Start: October 17, 2020
• Primary Completion: March 30, 2021
• Study Completion: September 17, 2021
• Last Updated: October 26, 2020

Record last verified: 2020-10

Locations

CN (1)