- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269151
Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD (LucERG)
April 7, 2015 updated by: Dr. Matthias Lueke, University of Luebeck
A Prospective, Non-randomized, Mono-center, Cohort Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections on Retinal Function in Patients With Wet Age-related Macular Degeneration During Twelve Month
Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal function.
No information besides visual acuity exist for the development of retinal function during the course of wet AMD during therapy with Lucentis.
The aim of our study is to evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early predictor of recurrence of the disease.
The second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-ERG during the course of wet AMD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
-
-
-
Lübeck, Germany, 23538
- University of Luebeck - Department of Ophthalmology
-
-
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients above 50 years of age
- wet age-related macular degeneration (AMD)
- an available follow-up of 12 months
- written informed consent
- visual acuity of 0.1 or better
Exclusion Criteria:
Systemic conditions or treatments
- history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
- clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within the last 6 months
- ventricular tachyarrythmias requiring ongoing treatment
- History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
- Clinically significant impaired renal or hepatic function
- Stroke within 12 month before trial entry.
- Known serious allergies to the fluorescein dye use in angiography
- Known contraindications to the components of Lucentis® formulation.
Ocular concomitant conditions/ diseases
- Active intraocular inflammation (grade trace or above) in either eye
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- History of uveitis in either eye
- Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion
- Angle block glaucoma
- Phthisis
- Intraocular Pressure <10mmHg
- Macular or retinal dystrophies
Compliance/ Administrative
- Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion.
- Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- Pregnant or nursing (lactating) women
- Inability to comply with study or follow-up procedures.
- Any treatment with an investigational agent in the past 3 months any condition.
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lucentis (Ranibizumab)
|
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
Time Frame: 12 months
|
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to document changes in optical coherence tomography (OCT)
Time Frame: 12 months
|
to document changes in optical coherence tomography (OCT)
|
12 months
|
to document changes in best corrected visual acuity (BCVA) measured on 4 meters,
Time Frame: 12 months
|
to document changes in best corrected visual acuity (BCVA) measured on 4 meters,
|
12 months
|
to document changes in angiography
Time Frame: 12 months
|
to document changes in angiography
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Salvatore Grisanti, M.D. Prof., University of Luebeck - Department of Ophthalmology: Germany
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, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 3, 2011
First Submitted That Met QC Criteria
January 3, 2011
First Posted (Estimate)
January 4, 2011
Study Record Updates
Last Update Posted (Estimate)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LucERG-001
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 Age-Related Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Hoffmann-La RocheNot yet recruitingNeovascular Age Related Macular Degeneration | nAMDChina
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheRecruitingNeovascular Age-Related Macular DegenerationBelgium, United States, Italy, Argentina, Spain, United Kingdom, Israel, Australia, Austria, Brazil, Germany, Switzerland, Taiwan, France
-
Hoffmann-La RocheCompletedNeovascular Age-Related Macular DegenerationUnited States
-
First Affiliated Hospital of Chongqing Medical...Enrolling by invitationExudative Age-Related Macular DegenerationChina
Clinical Trials on Lucentis (Ranibizumab)
-
University of Illinois at ChicagoGenentech, Inc.WithdrawnGlaucoma | Neovascular Glaucoma | New Onset Glaucoma | New Onset Neovascular Glaucoma
-
Vista KlinikCompletedAge Related Macular Degeneration | Choroidal NeovascularizationSwitzerland
-
The National Retina InstituteGenentech, Inc.Completed
-
Retina Associates of Cleveland, IncGenentech, Inc.UnknownDepression | Central Retinal Vein Occlusion | Retinal Vein Occlusion | Venous Retinal Branch OcclusionUnited States
-
Lawrence S. Morse, MDGenentech, Inc.CompletedAge Related Macular DegenerationUnited States
-
Southeast Clinical Research Associates, LLCGenentech, Inc.CompletedExudative Age Related Macular DegenerationUnited States
-
David M. Brown, M.D.Novartis PharmaceuticalsTerminatedAge-Related Macular DegenerationUnited States
-
Johns Hopkins UniversityJuvenile Diabetes Research FoundationCompletedDiabetic Macular EdemaUnited States
-
Lahey ClinicWithdrawn
-
Mid-Atlantic Retina Consultations, Inc.CompletedMacular Degeneration | Choroidal Neovascularization