Retinal Sensitivity in BRVO After Anti-VEGF Therapy

Phase 4

• Conditions: Branch Retinal Vein Occlusion
• Interventions: Drug: Ranibizumab; Drug: Ranibizumab and laser

• Registration Number: NCT02527733
• Lead Sponsor: Fukushima Medical University

Brief Summary

The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-29
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-17
• Last Update Submitted: 2015-08-17
• Study First Posted: 2015-08-19
• Last Update Posted: 2015-08-19
• Primary Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.

Exclusion Criteria

• Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.
Ranibizumab and laser	Ranibizumab and laser	After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.

Primary Outcome Measures

Name	Time	Method
Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)	At 12 months

Trial Locations

Locations (1)

Department of Ophthalmology, Fukushima Medical University; 🇯🇵 Fukushima, Japan