Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion

August 24, 2017 updated by: Jiro Kogo, St. Marianna University School of Medicine

To Investigate Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion

Primary Objective: To investigate the pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.

Secondary Objectives: Correlations between posttreatment BCVA and pretreatment factors were evaluated, including age, pretreatment BCVA, photoreceptor outer segment (PROS) length, central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer thickness (ONLT). The factors influencing posttreatment BCVA were evaluated using multiple regression analysis.

Detailed information on macular morphology, such as the photoreceptor IS/OS junction and ELM, can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹ Other investigators suggested that the thickness, area, and volume of the outer layer were correlated with BCVA in patients with dry age-related macular degeneration (AMD).² Outer foveal thickness (OFT) and relative reflectivity of the outer nuclear layer (ONL) were associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to be associated with BCVA in patients with AMD.5 The aim of this study was to investigate the pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed information on macular morphology, such as the photoreceptor IS/OS junction and ELM, can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹ Other investigators suggested that the thickness, area, and volume of the outer layer were correlated with BCVA in patients with dry age-related macular degeneration (AMD).² OFT and relative reflectivity of the ONL were associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to be associated with BCVA in patients with AMD.5 The aim of this study was to investigate the pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18, Patient of RVO, BCVA ≥ 0.1 (decimal visual acuity), Mean VRT≥ 250 μm
  • signed informed consent

Exclusion Criteria:

  • Laser photocoagulation for ME ≤ 4 months prior to initiation of this study therapy
  • Intraocular corticosteroid use ≤ 3 months prior to initiation of this study therapy
  • History of anti-VEGF treatment (intravitreal ≤3 months prior to initiation of this study therapy, systemic ≤ 6 months prior to initiation of this study therapy)
  • Stroke or myocardial infarction ≤ 3 months prior to initiation of this study
  • Pregnancy or potential pregnancy, and breastfeeding
  • Severe liver dysfunction, severe CKD/hemodialysis, uncontrolled DM (HbA1c>10), uncontrolled hypertension (BP≥ 160/100 mmHg)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab
Drug: Ranibizumab
0.5mg ranibizumab intravitreal injection
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity at 1 year after primary treatment
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
age, past medical history, complication (ex. Hypertension, Hyperlipidemia etc.), pretreatment BCVA, the photoreceptor outer segment (PROS) length, central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer thickness (ONLT)
Time Frame: baseline, 3months, 6months, 9month and 12months
baseline, 3months, 6months, 9month and 12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Marianna University School of Medicine

Investigators

  • Principal Investigator: Jiro Kogo, M.D., Ph. D., St. Marianna University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

March 22, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STM3247

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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