Overview

This trial is active, not recruiting.

Condition researcher-subject relations
Treatment ranibizumab
Target VEGF
Sponsor St. Marianna University School of Medicine
Start date March 2014
End date December 2016
Trial size 50 participants
Trial identifier NCT02144662, STM3247

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ranibizumab
ranibizumab Lucentis
0.5mg ranibizumab intravitreal injection

Primary Outcomes

Measure
Best-corrected visual acuity at 1 year after primary treatment
time frame: 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title To Investigate Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
Principal investigator Jiro Kogo, M.D., Ph. D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by St. Marianna University School of Medicine.