- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942864
Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
September 27, 2016 updated by: Novartis Korea Ltd.
An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 130-702
- Dept. of ophthalmology, Kyung Hee University Medical Center
-
-
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
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent
- Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT)
- Male and female aged from 18 to 70
- Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart
Exclusion Criteria:
- Additional eye disease that could compromise VA
- Ocular inflammation
- Intraocular surgery ≤ 1 month before day 0
- Uncontrolled glaucoma
- Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO
- Patients aged under 18 or over 71
- Female patient in pregnancy or breast feeding
- Not suitable to regular follow up
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.
Time Frame: every 4 weeks (up to 52 weeks)
|
every 4 weeks (up to 52 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc).
Time Frame: every 4 weeks (up to 52 weeks)
|
every 4 weeks (up to 52 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seung-Young Yu, Dept. ophthalmology, Kyunghee medical center
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
December 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
July 17, 2009
First Submitted That Met QC Criteria
July 20, 2009
First Posted (Estimate)
July 21, 2009
Study Record Updates
Last Update Posted (Estimate)
September 29, 2016
Last Update Submitted That Met QC Criteria
September 27, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Macular Degeneration
- Macular Edema
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- CRFB002AKR07
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.
Clinical Trials on Macular Edema
-
Federico II UniversityCompletedPseudophakic Cystoid Macular Edema
-
California Retina ConsultantsRegeneron PharmaceuticalsCompletedDiabetic Macular Edema | Cystoid Macular EdemaUnited States
-
Postgraduate Institute of Medical Education and...CompletedDiabetic Macular Edema | Vision Disorders | Macular Edema, Cystoid | Clinically Significant Macular EdemaIndia
-
OcugenNot yet recruitingDiabetic Macular Edema | Center Involved Diabetic Macular Edema
-
OculisICON plcRecruitingDiabetic Macular EdemaUnited States
-
Novartis PharmaceuticalsNot yet recruiting
-
Hoffmann-La RocheRecruitingUveitic Macular EdemaKorea, Republic of, United Kingdom, China, United States, Netherlands, Canada, Israel, Austria, Brazil, Italy, Taiwan, Poland, Portugal, Mexico
-
Vista KlinikNot yet recruitingDiabetic Macular Edema
-
Chinese University of Hong KongRecruiting
-
Laboratorios Sophia S.A de C.V.RecruitingDiabetic Macular EdemaColombia, Mexico
Clinical Trials on ranibizumab
-
University of Campania "Luigi Vanvitelli"Completed
-
University of Illinois at ChicagoGenentech, Inc.WithdrawnGlaucoma | Neovascular Glaucoma | New Onset Glaucoma | New Onset Neovascular Glaucoma
-
Especialistas en Retina Medica y Quirurgica Grupo...Centro de Retina Medica y Quirurgica S.C.CompletedDiabetic Macular EdemaArgentina, Mexico
-
Hanscom, Thomas, M.D.Genentech, Inc.CompletedCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionUnited States
-
Lupin Ltd.RecruitingNeovascular Age-related Macular DegenerationIndia
-
Hawaii Pacific HealthGenentech, Inc.CompletedPolypoidal Choroidal Vasculopathy | PCVUnited States
-
New England Retina AssociatesGenentech, Inc.CompletedChoroidal MelanomaUnited States
-
Samsung Bioepis Co., Ltd.CompletedAge-Related Macular DegenerationKorea, Republic of, United States, India, Germany, Hungary, United Kingdom, Czechia, Poland, Russian Federation
-
Peter A Campochiaro, MDGenentech, Inc.CompletedRetinal Vein OcclusionUnited States
-
Instituto de Olhos de GoianiaCompleted