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

Branch Retinal Vein Occlusion Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478515
• Other study ID #: PRNNCU001
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: March 2019

Study information

• Verified date: October 2016
• Source: Nagoya City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab
Intraviteal injection of 0.5mg ranibizumab

Locations

Country	Name	City	State
Japan	Nagoya City Univsersity	Nagoya	Aichi

Sponsors (2)

Lead Sponsor	Collaborator
Nagoya City University	Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	size and location of retinal non-perfusion area		one and two years
Primary	Visual acuity		One years
Secondary	central foveal thickness		One and two years
Secondary	Visual acuity		Two years