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Retinal Sensitivity in BRVO After Anti-VEGF Therapy

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ClinicalTrials.gov Identifier: NCT02527733
Recruitment Status : Unknown
Verified August 2015 by Akira Ojima, Fukushima Medical University.
Recruitment status was:  Recruiting
First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Akira Ojima, 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.

Condition or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion Drug: Ranibizumab Drug: Ranibizumab and laser Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retinal Sensitivity in Branch Retinal Vein Occlusion After Anti-VEGF Therapy
Study Start Date : June 2015
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: 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.
Drug: Ranibizumab
Active Comparator: 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.
Drug: Ranibizumab and laser



Primary Outcome Measures :
  1. Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan) [ Time Frame: At 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527733


Contacts
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Contact: Akira Ojima, M.D., Ph.D +81-24-548-2111 ao@fmu.ac.jp

Locations
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Japan
Department of Ophthalmology, Fukushima Medical University Recruiting
Fukushima, Japan, 9601295
Contact: Akira Ojima, M.D., Ph.D    +81-24-548-2111    ao@fmu.ac.jp   
Sponsors and Collaborators
Fukushima Medical University

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Responsible Party: Akira Ojima, Assistant Professor, Fukushima Medical University
ClinicalTrials.gov Identifier: NCT02527733     History of Changes
Other Study ID Numbers: 2129
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Immunological