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

• Status: Recruiting
• Trial end date: 2021-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: He Eye Hospital
• Treatments: Bevacizumab; Dexamethasone

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