- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384449
Lucentis (Ranibizumab) for Eales' Disease
June 9, 2019 updated by: Christina Flaxel, Oregon Health and Science University
The Use of a VEGF Inhibitor (Lucentis) in Refractory Macular Edema Due to Eales' Disease
The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease.
The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given.
Study Overview
Detailed Description
This is a six-month study.
Eligible subjects will receive one injection of the study drug into one eye for each of three months.
Visual acuity, blood pressure and eye pressure will be tested.
Subjects' retinas will be examined and thickness measured by optical coherence tomography (OCT).
Safety visits will be scheduled for the week after the injections.
The investigators will monitor the subjects' eyes for infection and inflammation.
After the three-month treatment period, subjects will return to the clinic monthly for four follow-up visits.
Procedures and tests that will be performed at the follow-up visits include visual acuity, a retinal exam including OCT, blood pressure, and eye pressure.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
- 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
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Casey Eye Institute
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age > 21 years.
- Disease related considerations:
For both treatment naïve and previously treated patients:
- exclusion of all other causes of cystoid macular edema and retinal nonperfusion including branch or central vein occlusion, diabetic retinopathy, sickle retinopathy, sarcoidosis, systemic lupus and other collagen vascular diseases
- chronic cystoid macular edema as noted clinically and on OCT 3 testing with persistent loss of visual acuity for 3 months or longer
- if the eye has received prior treatment (including laser photocoagulation and steroids) a 30 day washout period will be required prior to treatment with Lucentis.
- BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent) in the study eye.
- OCT 3 central subfield > or = 250 on 2 separate readings in the central subfield.
- Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.
Exclusion Criteria:
- Treatment for macular edema with intravitreal steroid or macugen within 30 days prior to enrollment in this study.
- Previous vitrectomy within the past 6 months.
- Previous cataract surgery within the preceding 12 months.
- Active intraocular inflammation in the study eye.
- Current vitreous hemorrhage in the study eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Participation in an investigational trial within 30 days of randomization that involved.
- Treatment with any drug that has not received regulatory approval at the time of study entry.
- Known allergy to any component of the study drug.
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
- If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
- Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
- Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment used during the 6 months of the study.
- Current treatment for active systemic infection.
- History of recurrent significant infections or bacterial infections.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 6 months of the study.
Subjects meeting any of the following criteria will be excluded from the study:
- Pregnancy (positive pregnancy test).
- Prior enrollment in the study.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lucentis (ranibizumab)
|
Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in OCT Thickness.
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
|
Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)
Time Frame: Monthly through Month 6
|
Monthly through Month 6
|
|
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Time Frame: Monthly through Month 6
|
No adverse events.
|
Monthly through Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters.
Time Frame: Months 3,4,5 and 6
|
Months 3,4,5 and 6
|
|
Incidence of Ocular and Non-ocular Adverse Events Evaluated Through Month 6.
Time Frame: Monthly through Month 6
|
No adverse events.
|
Monthly through Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christina J. Flaxel, MD, Casey Eye Institute, Oregon Health & Science University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
October 5, 2006
First Submitted That Met QC Criteria
October 5, 2006
First Posted (Estimate)
October 6, 2006
Study Record Updates
Last Update Posted (Actual)
June 11, 2019
Last Update Submitted That Met QC Criteria
June 9, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Diseases
- Vasculitis
- Metaplasia
- Neovascularization, Pathologic
- Retinal Vasculitis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- FVF3849s
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 Eales' Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Heart Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Arterial Occlusive DiseaseUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CelltrionRecruitingBowel Disease | Inflammatory Disease | Disease CrohnNetherlands
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Helix, IncMedical University of South Carolina; HealthPartners Institute; WellSpan Health; St. Luke's Hospital and Health Network, Pennsylvania and other collaboratorsRecruiting
-
Medtronic - MITGCompletedInflammatory Bowel Disease, Crohn DiseaseIsrael
-
Cynata Therapeutics LimitedRecruitingGraft Versus Host Disease, AcuteUnited States, Australia, Turkey
-
The Baruch Padeh Medical Center, PoriyaUnknown
-
Eye Hospital Pristina KosovoEnrolling by invitationProgressive Disease of CorneaeKosovo
Clinical Trials on Ranibizumab
-
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
-
University of Campania "Luigi Vanvitelli"Completed
-
Hanscom, Thomas, M.D.Genentech, Inc.CompletedCentral Retinal Vein Occlusion | Macular Edema | Branch Retinal Vein OcclusionUnited 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
-
Lupin Ltd.RecruitingNeovascular Age-related Macular DegenerationIndia
-
Hawaii Pacific HealthGenentech, Inc.CompletedPolypoidal Choroidal Vasculopathy | PCVUnited States
-
New England Retina AssociatesGenentech, Inc.CompletedChoroidal MelanomaUnited States
-
Vista KlinikCompletedAge Related Macular Degeneration | Choroidal NeovascularizationSwitzerland