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

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ClinicalTrials.gov Identifier: NCT04601701
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
He Eye Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone. Drug: Bevacizumab Ophthalmic. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on Central Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
Actual Study Start Date : October 17, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : September 17, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Avastin®


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Mean change in binocular BCVA [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters.


Secondary Outcome Measures :
  1. Mean change in central subfield retinal thickness [ Time Frame: Baseline, 1 week, 1 month, 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).

  2. Change in Humphrey 10-2 visual field in the treatment eye [ Time Frame: Baseline, 1 week, 1 month, 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.

  3. Number of Ranibizumab Treatments [ Time Frame: Day 1 through Month 6 ]
    Number of injections provided to the patients during the 6 month period.

  4. Mean change in NEI VFQ25 Questionnaire Score [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Scores from NEI VFQ25 questionnaire will be assessed and compared

  5. Mean change in VisQoL scores [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Scores from VisQoL questionnaire will be assessed and compared

  6. Mean change in wavefront aberrations [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III test

  7. Mean change in ocular surface and tear-film [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test

  8. Mean change in vessel density [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test

  9. Side effects [ Time Frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. ]
    Side effects are measured by a review of the participant's medical and ophthalmic history.

  10. Use of additional treatments (including laser) [ Time Frame: Day 1 through Month 6 ]
    Use of additional treatments (including laser) is assessed by the treating ophthalmologist

  11. People meeting driving standards [ Time Frame: Baseline, 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601701


Contacts
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Contact: Jun Li, M.D., Ph.D. 0086-411-86525401 robin_lijun@sina.com
Contact: Emmanuel E Pazo, M.D., Ph.D. 008618612782131 ericpazo@outlook.com

Locations
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China, Liaoning
He Eye Specialist Hospital Recruiting
Shenyang, Liaoning, China, 110001
Contact: Jun Li, M.D., Ph.D.    0086-411-86525401    robin_lijun@sina.com   
Contact: Emmanuel E Pazo, M.D., Ph.D.    008618612782131    ericpazo@outlook.com   
Sub-Investigator: Lanting Yang, M.D.         
Sub-Investigator: Qiqi Zhong, M.D.         
Sponsors and Collaborators
He Eye Hospital
Investigators
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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.
More Information
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Responsible Party: He Eye Hospital
ClinicalTrials.gov Identifier: NCT04601701    
Other Study ID Numbers: ME-270620
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal