Retinal Sensitivity in BRVO After Anti-VEGF Therapy

Sponsor

Fukushima Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02527733

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Ranibizumab

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

Outcome Measures

Primary Outcome Measures

Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan) [At 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Fukushima Medical University	Fukushima		Japan	9601295

Sponsors and Collaborators

Fukushima Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Akira Ojima, Assistant Professor, Fukushima Medical University

ClinicalTrials.gov Identifier:

NCT02527733

Other Study ID Numbers:

2129

First Posted:

Aug 19, 2015

Last Update Posted:

Aug 19, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Retinal Vein Occlusion

Ranibizumab

Study Results

No Results Posted as of Aug 19, 2015