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

Researcher-Subject Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144662
• Other study ID #: STM3247
• Status: Completed
• Phase: N/A
• First received: March 22, 2014
• Last updated: August 24, 2017
• Start date: March 2014
• Est. completion date: April 30, 2017

Study information

• Verified date: August 2017
• Source: St. Marianna University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Researcher-Subject Relations
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab
0.5mg ranibizumab intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Marianna University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity at 1 year after primary treatment		1 year
Secondary	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)		baseline, 3months, 6months, 9month and 12months