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

NCT02144662 | Completed DMC

• 1 other identifier: STM3247
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Researcher-Subject Relations

Outcome Measures

Primary Outcomes (1)

• Best-corrected visual acuity at 1 year after primary treatment

  1 year

Secondary Outcomes (1)

• 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

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Ranibizumab

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

0.5mg ranibizumab intravitreal injection

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Marianna University School of Medicine: lead

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jiro Kogo, M.D., Ph. D.

  St. Marianna University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology

Study Record Dates

• First Submitted: March 22, 2014
• First Posted: May 22, 2014
• Study Start: March 1, 2014
• Primary Completion: January 31, 2017
• Study Completion: April 30, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08