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

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

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.

Study Overview

• Status: Unknown
• Conditions: Central Retinal Vein Occlusion
• Intervention / Treatment: Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone.; Drug: Bevacizumab Ophthalmic.

Detailed Description

Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central and hemi vein occlusions. Until recently the standard of care for macular edema secondary to central retinal vein occlusion was observation. Recent investigations of steroids for this condition has shown greater visual benefit but is associated with risks such as cataract formation and increased intraocular pressure. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO.

Bevacizumab, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Bevacizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to steroids.

Ozurdex (dexamethasone) Intravitreal Implant is a steroid injected into the eye to treat swelling that may occur when there is a blockage of certain blood vessels in your eyes. Ozurdex is also used to treat non-infectious uveitis affecting the posterior (rear) segment of the eye.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • He Eye Specialist Hospital
      • Sub-Investigator: Qiqi Zhong, M.D.
      • Sub-Investigator: Lanting Yang, M.D.
      • Contact: Jun Li, M.D., Ph.D.; Phone Number: 0086-411-86525401; Email: robin_lijun@sina.com
      • Contact: Emmanuel E Pazo, M.D., Ph.D.; Phone Number: 008618612782131; Email: ericpazo@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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 CRVO
3. BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 1 week, 1 month, 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.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Number of Ranibizumab Treatments	Number of injections provided to the patients during the 6 month period.	Day 1 through Month 6
Mean change in NEI VFQ25 Questionnaire Score	Scores from NEI VFQ25 questionnaire will be assessed and compared	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores	Scores from VisQoL questionnaire will be assessed and compared	Baseline, 1 week, 1 month, 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 test	Baseline, 1 week, 1 month, 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	Baseline, 1 week, 1 month, 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	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects	Side effects are measured by a review of the participant's medical and ophthalmic history.	Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)	Use of additional treatments (including laser) is assessed by the treating ophthalmologist	Day 1 through Month 6
People meeting driving standards	Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test	Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.

Collaborators and Investigators

• Sponsor: He Eye Hospital
• Investigators: Study Chair: Wei He, M.D., Ph.D., He Eye Specialist Hospital, Shenyang.; Principal Investigator: Jun Li, M.D., Ph.D., He Eye Specialist Hospital, Shenyang.; Study Director: Emmanuel E Pazo, M.D., Ph.D., He Eye Specialist Hospital, Shenyang.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): September 17, 2021

Study Registration Dates

• First Submitted: August 26, 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: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Bevacizumab
• Other Study ID Numbers: ME-270620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No