Trial | NCT04601701  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
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 Started
Oct 17
2020
Primary Completion
Mar 30
2021
Anticipated
Study Completion
Sep 17
2021
Anticipated
Last Update
Oct 26
2020

Drug Bevacizumab Ophthalmic and Intravitreal Dexamethasone. [bevacizumab (avastin), 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®

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®

CRVO: Bevacizumab and intravitreal Dexamethasone. Experimental

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

CRVO: Bevacizumab Active Comparator

Participants with CRVO will receive a combination of Bevacizumab only.

Criteria 

Inclusion Criteria:

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)

Exclusion Criteria:

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
No Results Posted