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

NCT02478515 | Completed Phase 4

• 1 other identifier: PRNNCU001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Branch Retinal Vein Occlusion

Keywords

ranibizumab; PRN regimen; macular edema; branch retinal vein occlusion

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  One years

Secondary Outcomes (2)

• central foveal thickness

  One and two years

• Visual acuity

  Two years

Other Outcomes (1)

• size and location of retinal non-perfusion area

  one and two years

Study Arms (1)

Intraviteal Ranibizumab 0.5mg

EXPERIMENTAL

Intraviteal Ranibizumab 0.5mg

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intraviteal injection of 0.5mg ranibizumab

Also known as: Lucentis

Intraviteal Ranibizumab 0.5mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nagoya City University: lead
• Novartis: collaborator

Study Sites (1)

Nagoya City Univsersity

Nagoya, Aichi-ken, 467-8602, Japan

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yuichiro Ogura

  Nagoya City Univsersity

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: June 23, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 20, 2019

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)