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Retinal Sensitivity in BRVO After Anti-VEGF Therapy

F

Fukushima Medical University

Status and phase

Unknown
Phase 4

Conditions

Branch Retinal Vein Occlusion

Treatments

Drug: Ranibizumab
Drug: Ranibizumab and laser

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Ranibizumab
Active Comparator group
Description:
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.
Treatment:
Drug: Ranibizumab
Ranibizumab and laser
Active Comparator group
Description:
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.
Treatment:
Drug: Ranibizumab and laser

Trial contacts and locations

1

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Central trial contact

Akira Ojima, M.D., Ph.D

Data sourced from clinicaltrials.gov

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