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Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD (LucERG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269151
First Posted: January 4, 2011
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Matthias Lueke, University of Luebeck
  Purpose
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.

Condition Intervention
Age-Related Macular Degeneration Retinal Function Drug: Lucentis (Ranibizumab)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dr. Matthias Lueke, University of Luebeck:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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,

  • to document changes in angiography [ Time Frame: 12 months ]
    to document changes in angiography

  • to document changes in optical coherence tomography (OCT) [ Time Frame: 12 months ]
    to document changes in optical coherence tomography (OCT)


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: April 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucentis (Ranibizumab) Drug: Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients above 50 years of age
  2. wet age-related macular degeneration (AMD)
  3. an available follow-up of 12 months
  4. written informed consent
  5. visual acuity of 0.1 or better

Exclusion Criteria:

Systemic conditions or treatments

  1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
  2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within the last 6 months
  3. ventricular tachyarrythmias requiring ongoing treatment
  4. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
  5. Clinically significant impaired renal or hepatic function
  6. Stroke within 12 month before trial entry.
  7. Known serious allergies to the fluorescein dye use in angiography
  8. Known contraindications to the components of Lucentis® formulation.

Ocular concomitant conditions/ diseases

  1. Active intraocular inflammation (grade trace or above) in either eye
  2. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
  3. History of uveitis in either eye
  4. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion
  5. Angle block glaucoma
  6. Phthisis
  7. Intraocular Pressure <10mmHg
  8. Macular or retinal dystrophies

Compliance/ Administrative

  1. 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.
  2. Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.
  3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  4. Pregnant or nursing (lactating) women
  5. Inability to comply with study or follow-up procedures.
  6. Any treatment with an investigational agent in the past 3 months any condition.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01269151


Locations
Germany
University of Luebeck - Department of Ophthalmology
Lübeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Salvatore Grisanti, M.D. Prof. University of Luebeck - Department of Ophthalmology: Germany
  More Information

Additional Information:
Responsible Party: Dr. Matthias Lueke, Dr. med. Matthias Lüke, University of Luebeck
ClinicalTrials.gov Identifier: NCT01269151     History of Changes
Other Study ID Numbers: LucERG-001
First Submitted: January 3, 2011
First Posted: January 4, 2011
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Dr. Matthias Lueke, University of Luebeck:
Age-Related Macular Degeneration
Retinal Function
multifocal-ERG
Electroretinography
microperimetry
Lucentis
Ranibizumab
longterm effects
best corrected visual acuity
BCVA

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents