Clinical trial NCT04601701: Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
Official title: Study on Central Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Retinal Vein Occlusion
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean change in monocular BCVA in the treatment eye
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
measure: Mean change in binocular BCVA
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Secondary outcomes:
measure: Mean change in central subfield retinal thickness
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Change in Humphrey 10-2 visual field in the treatment eye
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Number of Ranibizumab Treatments
timeFrame: Day 1 through Month 6
measure: Mean change in NEI VFQ25 Questionnaire Score
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in VisQoL scores
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in wavefront aberrations
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in ocular surface and tear-film
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Mean change in vessel density
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Side effects
timeFrame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
measure: Use of additional treatments (including laser)
timeFrame: Day 1 through Month 6
measure: People meeting driving standards
timeFrame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Specialist Hospital
state: Liaoning
Study officials:
affiliation: He Eye Specialist Hospital, Shenyang.
name: Wei He, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: He Eye Specialist Hospital, Shenyang.
name: Jun Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: He Eye Specialist Hospital, Shenyang.
name: Emmanuel E Pazo, M.D., Ph.D.
role: STUDY_DIRECTOR
References: