Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
Primary Purpose
Researcher-Subject Relations
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Researcher-Subject Relations
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab
Arm Description
Ranibizumab
Outcomes
Primary Outcome Measures
Best-corrected visual acuity at 1 year after primary treatment
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02144662
First Posted
March 22, 2014
Last Updated
August 24, 2017
Sponsor
St. Marianna University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02144662
Brief Title
Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
Official Title
To Investigate Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Marianna University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Researcher-Subject Relations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5mg ranibizumab intravitreal injection
Primary Outcome Measure Information:
Title
Best-corrected visual acuity at 1 year after primary treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiro Kogo, M.D., Ph. D.
Organizational Affiliation
St. Marianna University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
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