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NCT02527733 Clinical Trial

Retinal Sensitivity in BRVO After Anti-VEGF Therapy

Branch Retinal Vein Occlusion Clinical Trial

Official title:
Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02527733
Other study ID # 2129
Secondary ID
Status Recruiting
Phase Phase 4
First received June 29, 2015
Last updated August 17, 2015
Start date June 2015

Study information
Verified date August 2015
Source Fukushima Medical University
Contact Akira Ojima, M.D., Ph.D
Phone +81-24-548-2111
Email ao@fmu.ac.jp
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ranibizumab

• Ranibizumab and laser

Locations
Country Name City State
Japan Department of Ophthalmology, Fukushima Medical University Fukushima

Sponsors (1)
Lead Sponsor Collaborator
Fukushima Medical University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan) At 12 months No
See also
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Not yet recruiting NCT04601688 - Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only. N/A
Completed NCT01968239 - Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT Phase 2
Completed NCT00612261 - Sheathotomy vs. Intravitreal Triamcinolone for Branch Retinal Vein Occlusion N/A
Not yet recruiting NCT03637283 - Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage N/A
Completed NCT01976338 - Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO) Phase 3
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Active, not recruiting NCT04120636 - Phase I Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole Phase 1
Recruiting NCT01975103 - Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases Phase 2
Recruiting NCT01348633 - Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye N/A
Completed NCT04740905 - A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion Phase 3
Completed NCT01396057 - Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO) Phase 3
Terminated NCT03802630 - Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion Phase 3
Completed NCT02478515 - Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion Phase 4
Terminated NCT01795209 - Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision Phase 4