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

Central Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04601701
• Other study ID #: ME-270620
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2020
• Est. completion date: September 17, 2021

Study information

• Verified date: October 2020
• Source: He Eye Hospital
• Contact: Jun Li, M.D., Ph.D.
• Phone: 0086-411-86525401
• Email: robin_lijun[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 17, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
China	He Eye Specialist Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Number of Ranibizumab Treatments	Number of injections provided to the patients during the 6 month period.	Day 1 through Month 6
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Use of additional treatments (including laser)	Use of additional treatments (including laser) is assessed by the treating ophthalmologist	Day 1 through Month 6
Secondary	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.