Retinal Sensitivity in BRVO After Anti-VEGF Therapy

NCT02527733 | Unknown Phase 4

• 1 other identifier: 2129
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Branch Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)

  At 12 months

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

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

Ranibizumab and laser

ACTIVE COMPARATOR

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

Interventions

Ranibizumab DRUG

Ranibizumab

Ranibizumab and laser DRUG

Ranibizumab and laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fukushima Medical University: lead

Study Sites (1)

Department of Ophthalmology, Fukushima Medical University

Fukushima, Fukushima, 9601295, Japan

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab; Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Akira Ojima, M.D., Ph.D

CONTACT

+81-24-548-2111; ao@fmu.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: August 19, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

JP (1)