Evaluation of the Usefulness of a PRN Regimen Using Ranibizumab for Macular Edema Due to Branch Retinal Vein Occlusion

Sponsor

Nagoya City University (Other)

Overall Status

Completed

CT.gov ID

NCT02478515

Collaborator

Novartis (Industry)

Enrollment

Location

Arm

61.9

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Monthly intravitreal ranibizumab (IVR) during the first 6 month had great effect for macular edema with branch retinal vein occlusion (BVO) both in visual and anatomical outcome. It is expected that similar results could be obtained by less frequent IVR. The purpose of this study is to investigate if IVR by PRN is as effective as by monthly. In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area.

Condition or Disease	Intervention/Treatment	Phase
Branch Retinal Vein Occlusion	Drug: Ranibizumab	Phase 4

Detailed Description

It was demonstrated in BRAVO study that IVR had great effect for macular edema with BVO both in visual and anatomical outcome. However IVR was done monthly for all patients (except Sham group) during the first 6 months in BRAVO study. It is expected that similar results could be obtained by less frequent IVR, and if so, it will contribute to reduce patient's burden and medical cost. Thus it is necessary to determine the optimal regimen of IVR therapy.

In this study, considering the medical and social circumstances in Japan, the investigators are going to investigate if IVR by PRN is as effective as BRAVO study.In addition, the investigators are going to study the relationship between macular edema and the size and location of retinal non-perfusion area (NPA), because VEGF is thought to be released from non-perfused retinal tissue, and VEGF production may be correlated with NPA size and location. The investigators are going to measure the size of NPA semi-quantatively by ultra wide field fluorescein angiography (UWFA) using Optos 200Tx. Then the relationship with macular edema will be studied. The effect of ranibizumab to NPA is controversial. In this study, it will be investigated, too.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Visual Acuity Improvement of a PRN Regimen Using Ranibizumab for Macular Edema Due to Ischemic and Non- Ischemic Branch Retinal Vein Occlusion.

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intraviteal Ranibizumab 0.5mg Intraviteal Ranibizumab 0.5mg	Drug: Ranibizumab Intraviteal injection of 0.5mg ranibizumab Other Names: Lucentis

Arm

Intervention/Treatment

Experimental: Intraviteal Ranibizumab 0.5mg

Intraviteal Ranibizumab 0.5mg

Drug: Ranibizumab

Intraviteal injection of 0.5mg ranibizumab

Other Names:

Lucentis

Outcome Measures

Primary Outcome Measures

Visual acuity [One years]

Secondary Outcome Measures

central foveal thickness [One and two years]
Visual acuity [Two years]

Other Outcome Measures

size and location of retinal non-perfusion area [one and two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent form
Macula edema secondary to BRVO
BCVA of 77 to 20 letters assessed with the use of ETDRS charts
CRT ≧250μm

Exclusion Criteria:

Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
Ocular disorders in the study eye that may confound interpretation of study results
BCVA over 77 letters between screening and Day 0
The pregnant or lactating woman